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Search / Trial NCT04205968

Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

Launched by SWOG CANCER RESEARCH NETWORK · Dec 18, 2019

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether a combination of two treatments—ramucirumab and either paclitaxel or a chemotherapy regimen called FOLFIRI—can help patients with advanced small bowel cancers. These cancers may have spread to other parts of the body or are not responding to previous treatments. Ramucirumab is a type of medication that helps block the growth of new blood vessels that tumors need to grow, while the chemotherapy drugs work to kill or stop the growth of cancer cells. The goal of the study is to see if this combination can improve treatment outcomes and help patients live longer.

To participate in this trial, patients must have a confirmed diagnosis of small bowel adenocarcinoma that has spread or cannot be surgically removed. They should have previously received treatment that included certain chemotherapy drugs and must be in good health overall, meaning they can perform daily activities without much difficulty. Participants will undergo regular assessments to monitor their health and the effectiveness of the treatments. It’s important to note that patients with certain medical conditions or those who have received specific treatments recently may not be eligible for this trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must have metastatic disease or locally advanced unresectable disease
  • Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to registration. Patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration
  • Patients must have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic/locally advanced disease or as adjuvant therapy completed within the previous 12 months
  • Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to grade 1 (with the exception of grade 2 neuropathy) prior to registration. In Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
  • Patients must have a complete medical history and physical exam within 28 days prior to registration
  • Patients must have a Zubrod performance status of 0 or 1
  • Absolute neutrophil count (ANC) \>= 1,500/mcL (must be obtained within 28 days prior to registration)
  • Platelets \>= 100,000/mcL (must be obtained within 28 days prior to registration)
  • A total bilirubin =\< 1.5 x institutional limit normal (IULN) (must be obtained within 28 days prior to registration)
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.0 x IULN (or 5.0 x IULN if liver metastases are present) (must be obtained within 28 days prior to registration)
  • Serum creatinine =\< 1.5 x IULN OR calculated creatinine clearance \>= 40 mL/min (must have been obtained within 28 days prior to registration)
  • Patient must have urinary protein =\< 1+ on dipstick or routine urinalysis (UA) within 28 days prior to registration. If dipstick or routine analysis is \>= 2+, a 24 - hour urine collections for protein must demonstrate \< 1000 mg of protein in 24 hours
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients must not have known dihydropyrimidine dehydrogenase deficiency
  • Patients must be offered the opportunity to participate in specimen banking
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • Exclusion Criteria:
  • Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma
  • Patients must not have had major surgery within 28 days prior to registration, or minor surgery within 7 days prior to registration, and must not be planned for elective major surgery to be performed during protocol treatment
  • Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study
  • Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents
  • Patient must not have a known bleeding diathesis
  • Patient must not have uncontrolled or poorly-controlled hypertension (\> 160 mmHg systolic or \> 100 mg HG diastolic for \> 4 weeks) despite standard medical management
  • Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H)
  • Patients must not be pregnant or nursing and must have had a negative pregnancy test within 4 weeks of starting treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have an active infection requiring systemic therapy
  • Patient must not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 90 days prior to registration
  • Patients must not have experienced any arterial thrombotic event (including but not limited to myocardial infarction, unstable angina, stable angina markedly limiting ordinary physical activity, cerebrovascular accident, or transient ischemic attack) within 120 days prior to registration
  • Patients must not have a prior history of gastrointestinal (GI) perforation/fistula or other risk factors for perforation within 120 days prior to registration
  • Patients must not have experienced any grade 3-4 GI bleeding within 90 days prior to registration
  • Patient must not have experienced any serious or non-healing wound, ulcer, or bone fracture within 28 days prior to registration

About Swog Cancer Research Network

The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.

Locations

Chicago, Illinois, United States

Buffalo, New York, United States

Saint Louis, Missouri, United States

Flint, Michigan, United States

Denver, Colorado, United States

Flint, Michigan, United States

Burnsville, Minnesota, United States

Edina, Minnesota, United States

Waconia, Minnesota, United States

Peoria, Illinois, United States

Anchorage, Alaska, United States

Oklahoma City, Oklahoma, United States

Des Moines, Iowa, United States

Great Falls, Montana, United States

Saint Paul, Minnesota, United States

Ann Arbor, Michigan, United States

Bozeman, Montana, United States

Kalispell, Montana, United States

Sheridan, Wyoming, United States

Cincinnati, Ohio, United States

Las Vegas, Nevada, United States

Houston, Texas, United States

Dallas, Texas, United States

Las Vegas, Nevada, United States

Mount Vernon, Illinois, United States

Yakima, Washington, United States

Coon Rapids, Minnesota, United States

Renton, Washington, United States

Urbana, Illinois, United States

Carroll, Iowa, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Shakopee, Minnesota, United States

Willmar, Minnesota, United States

Council Bluffs, Iowa, United States

Dayton, Ohio, United States

Effingham, Illinois, United States

Saint Joseph, Missouri, United States

Greenville, Ohio, United States

Bethlehem, Pennsylvania, United States

Wisconsin Rapids, Wisconsin, United States

Longmont, Colorado, United States

Springfield, Illinois, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

Springfield, Illinois, United States

Minneapolis, Minnesota, United States

Rochester, New York, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Detroit, Michigan, United States

Southfield, Michigan, United States

Duluth, Minnesota, United States

Saint Louis, Missouri, United States

Kearney, Nebraska, United States

Aurora, Illinois, United States

Charlotte, North Carolina, United States

Kettering, Ohio, United States

Allentown, Pennsylvania, United States

Centralia, Washington, United States

Federal Way, Washington, United States

Lakewood, Washington, United States

Cape Girardeau, Missouri, United States

Coos Bay, Oregon, United States

Pueblo, Colorado, United States

Fridley, Minnesota, United States

Robbinsdale, Minnesota, United States

Saint Louis Park, Minnesota, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Memphis, Tennessee, United States

Omaha, Nebraska, United States

Fort Lauderdale, Florida, United States

Dallas, Texas, United States

Detroit, Michigan, United States

Rochester, Minnesota, United States

Saint Louis, Missouri, United States

Las Vegas, Nevada, United States

Marshfield, Wisconsin, United States

Portland, Oregon, United States

Reno, Nevada, United States

Decatur, Illinois, United States

Ottawa, Illinois, United States

Peoria, Illinois, United States

Missoula, Montana, United States

Galesburg, Illinois, United States

Clive, Iowa, United States

Des Moines, Iowa, United States

Des Moines, Iowa, United States

Des Moines, Iowa, United States

Lansing, Michigan, United States

Warren, Michigan, United States

Brainerd, Minnesota, United States

Duluth, Minnesota, United States

Duluth, Minnesota, United States

Lincoln, Nebraska, United States

Papillion, Nebraska, United States

Anchorage, Alaska, United States

Omaha, Nebraska, United States

Cape Girardeau, Missouri, United States

Peru, Illinois, United States

Des Moines, Iowa, United States

Adrian, Michigan, United States

Livonia, Michigan, United States

Monroe, Michigan, United States

Pontiac, Michigan, United States

Maplewood, Minnesota, United States

Maplewood, Minnesota, United States

Stillwater, Minnesota, United States

Great Falls, Montana, United States

Findlay, Ohio, United States

Maumee, Ohio, United States

Toledo, Ohio, United States

Bremerton, Washington, United States

Burbank, California, United States

Los Angeles, California, United States

Alton, Illinois, United States

Galesburg, Illinois, United States

Richmond, Indiana, United States

Ames, Iowa, United States

Bettendorf, Iowa, United States

Saginaw, Michigan, United States

Woodbury, Minnesota, United States

Joplin, Missouri, United States

Springfield, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Missoula, Montana, United States

Reno, Nevada, United States

Boardman, Ohio, United States

Dayton, Ohio, United States

Franklin, Ohio, United States

Toledo, Ohio, United States

Troy, Ohio, United States

Warren, Ohio, United States

Youngstown, Ohio, United States

East Stroudsburg, Pennsylvania, United States

Tacoma, Washington, United States

Vancouver, Washington, United States

Minocqua, Wisconsin, United States

Oconomowoc, Wisconsin, United States

Rice Lake, Wisconsin, United States

Waukesha, Wisconsin, United States

Wausau, Wisconsin, United States

Weston, Wisconsin, United States

Kettering, Ohio, United States

San Diego, California, United States

Colorado Springs, Colorado, United States

Lakewood, Colorado, United States

Springfield, Ohio, United States

Bellingham, Washington, United States

Seattle, Washington, United States

Seattle, Washington, United States

Livonia, Michigan, United States

Bremerton, Washington, United States

Kennewick, Washington, United States

Sedro Woolley, Washington, United States

Clackamas, Oregon, United States

Newberg, Oregon, United States

Littleton, Colorado, United States

New Ulm, Minnesota, United States

Boise, Idaho, United States

Las Vegas, Nevada, United States

Louisville, Kentucky, United States

Chippewa Falls, Wisconsin, United States

Canton, Illinois, United States

Carthage, Illinois, United States

Eureka, Illinois, United States

Kewanee, Illinois, United States

Macomb, Illinois, United States

Peru, Illinois, United States

Princeton, Illinois, United States

Boise, Idaho, United States

Fargo, North Dakota, United States

Parker, Colorado, United States

Joplin, Missouri, United States

Walla Walla, Washington, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Grand Island, Nebraska, United States

Fort Smith, Arkansas, United States

Santa Rosa, California, United States

Post Falls, Idaho, United States

Bloomington, Illinois, United States

Pekin, Illinois, United States

Fergus Falls, Minnesota, United States

Bolivar, Missouri, United States

Branson, Missouri, United States

Saint Louis, Missouri, United States

Concord, North Carolina, United States

Lawton, Oklahoma, United States

Bend, Oregon, United States

Boiling Springs, South Carolina, United States

Easley, South Carolina, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Greer, South Carolina, United States

Seneca, South Carolina, United States

Poulsbo, Washington, United States

Carmichael, California, United States

Saint Johnsbury, Vermont, United States

Hot Springs, Arkansas, United States

Arroyo Grande, California, United States

Jefferson City, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Oklahoma City, Oklahoma, United States

Bryan, Texas, United States

Longview, Washington, United States

Anaheim, California, United States

Baldwin Park, California, United States

Bellflower, California, United States

Fontana, California, United States

Harbor City, California, United States

Irvine, California, United States

Los Angeles, California, United States

Panorama City, California, United States

Riverside, California, United States

San Diego, California, United States

San Marcos, California, United States

Woodland Hills, California, United States

Fruitland, Idaho, United States

Meridian, Idaho, United States

Nampa, Idaho, United States

Twin Falls, Idaho, United States

West Des Moines, Iowa, United States

Rolla, Missouri, United States

Rolla, Missouri, United States

Monroe, North Carolina, United States

Oregon City, Oregon, United States

Bellevue, Washington, United States

Burien, Washington, United States

Edmonds, Washington, United States

Everett, Washington, United States

Issaquah, Washington, United States

Lacey, Washington, United States

New Richmond, Wisconsin, United States

Urbana, Illinois, United States

Springfield, Illinois, United States

Longmont, Colorado, United States

Las Vegas, Nevada, United States

Springfield, Ohio, United States

Saint Peters, Missouri, United States

Anchorage, Alaska, United States

Caldwell, Idaho, United States

Coeur D'alene, Idaho, United States

Emmett, Idaho, United States

Meridian, Idaho, United States

Nampa, Idaho, United States

Sandpoint, Idaho, United States

Clive, Iowa, United States

West Des Moines, Iowa, United States

Garden City, Kansas, United States

Great Bend, Kansas, United States

Brighton, Michigan, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Canton, Michigan, United States

Caro, Michigan, United States

Chelsea, Michigan, United States

Chelsea, Michigan, United States

Clarkston, Michigan, United States

Clarkston, Michigan, United States

East China Township, Michigan, United States

Farmington Hills, Michigan, United States

Flint, Michigan, United States

Flint, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Livonia, Michigan, United States

Macomb, Michigan, United States

Macomb, Michigan, United States

Marlette, Michigan, United States

Pontiac, Michigan, United States

Pontiac, Michigan, United States

Pontiac, Michigan, United States

Rochester Hills, Michigan, United States

Saginaw, Michigan, United States

Sterling Heights, Michigan, United States

Warren, Michigan, United States

Warren, Michigan, United States

Warren, Michigan, United States

Warren, Michigan, United States

West Branch, Michigan, United States

Ypsilanti, Michigan, United States

Ypsilanti, Michigan, United States

Minneapolis, Minnesota, United States

Anaconda, Montana, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Centerville, Ohio, United States

Baker City, Oregon, United States

Ontario, Oregon, United States

Cody, Wyoming, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Colorado Springs, Colorado, United States

Durango, Colorado, United States

Durango, Colorado, United States

Creston, Iowa, United States

Bardstown, Kentucky, United States

Corbin, Kentucky, United States

Lexington, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Shepherdsville, Kentucky, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Aberdeen, Washington, United States

Enumclaw, Washington, United States

Seattle, Washington, United States

Shelton, Washington, United States

Tacoma, Washington, United States

Yelm, Washington, United States

Carbondale, Illinois, United States

Carterville, Illinois, United States

Centralia, Illinois, United States

Danville, Illinois, United States

Decatur, Illinois, United States

Effingham, Illinois, United States

Mattoon, Illinois, United States

New Lenox, Illinois, United States

O'fallon, Illinois, United States

Swansea, Illinois, United States

Yorkville, Illinois, United States

Louisville, Kentucky, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Ypsilanti, Michigan, United States

Maple Grove, Minnesota, United States

Wyoming, Minnesota, United States

Sainte Genevieve, Missouri, United States

Sullivan, Missouri, United States

Sunset Hills, Missouri, United States

Centerville, Ohio, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Findlay, Ohio, United States

Findlay, Ohio, United States

Franklin, Ohio, United States

Greenville, Ohio, United States

Kettering, Ohio, United States

Troy, Ohio, United States

Clackamas, Oregon, United States

Seattle, Washington, United States

Ames, Iowa, United States

Boone, Iowa, United States

Fort Dodge, Iowa, United States

Jefferson, Iowa, United States

Marshalltown, Iowa, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Novi, Michigan, United States

Monticello, Minnesota, United States

Grenada, Mississippi, United States

New Albany, Mississippi, United States

Oxford, Mississippi, United States

Southhaven, Mississippi, United States

Creve Coeur, Missouri, United States

Saint Louis, Missouri, United States

Carson City, Nevada, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Reno, Nevada, United States

Eau Claire, Wisconsin, United States

Stevens Point, Wisconsin, United States

Ladysmith, Wisconsin, United States

London, Kentucky, United States

Mukwonago, Wisconsin, United States

Waukesha, Wisconsin, United States

Ontario, California, United States

Des Moines, Iowa, United States

Ashland, Wisconsin, United States

Orland Park, Illinois, United States

Charlotte, North Carolina, United States

Phoenix, Arizona, United States

Elk Grove, California, United States

Rocklin, California, United States

Sacramento, California, United States

San Luis Obispo, California, United States

Santa Maria, California, United States

Woodland, California, United States

Tawas City, Michigan, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Perrysburg, Ohio, United States

Brewer, Maine, United States

Seattle, Washington, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Pahrump, Nevada, United States

Albemarle, North Carolina, United States

Charlotte, North Carolina, United States

Charlotte, North Carolina, United States

Beavercreek, Ohio, United States

Stevens Point, Wisconsin, United States

Arroyo Grande, California, United States

Springfield, Massachusetts, United States

Aitkin, Minnesota, United States

Deer River, Minnesota, United States

Hibbing, Minnesota, United States

Sandstone, Minnesota, United States

Virginia, Minnesota, United States

Hazleton, Pennsylvania, United States

Collierville, Tennessee, United States

Ashland, Wisconsin, United States

Ballwin, Missouri, United States

Washington, Missouri, United States

Fort Dodge, Iowa, United States

Redmond, Oregon, United States

Lake Forest, Illinois, United States

Detroit Lakes, Minnesota, United States

Fosston, Minnesota, United States

Park Rapids, Minnesota, United States

Jamestown, North Dakota, United States

Brighton, Michigan, United States

Kingman, Arizona, United States

Fort Myers, Florida, United States

Dixon, Illinois, United States

Washington, Illinois, United States

Farmington, Missouri, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Henderson, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Las Vegas, Nevada, United States

Santa Rosa, California, United States

Colorado Springs, Colorado, United States

Burnsville, Minnesota, United States

Cambridge, Minnesota, United States

Princeton, Minnesota, United States

Carmichael, California, United States

Baxter, Minnesota, United States

Ely, Minnesota, United States

International Falls, Minnesota, United States

Moose Lake, Minnesota, United States

Napa, California, United States

Hayward, Wisconsin, United States

Spooner, Wisconsin, United States

Superior, Wisconsin, United States

Lexington, Kentucky, United States

Des Moines, Iowa, United States

Mount Sterling, Kentucky, United States

Lebanon, New Hampshire, United States

Troy, Ohio, United States

Nampa, Idaho, United States

Centralia, Illinois, United States

Danville, Illinois, United States

Boone, Iowa, United States

Fort Dodge, Iowa, United States

Jefferson, Iowa, United States

Marshalltown, Iowa, United States

Ames, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Michael J Overman

Principal Investigator

SWOG Cancer Research Network

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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