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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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Ann Arbor, Michigan, United States
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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
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Cincinnati, Ohio, United States
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Fort Lauderdale, Florida, United States
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Brainerd, Minnesota, United States
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Peru, Illinois, United States
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Maplewood, Minnesota, United States
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Findlay, Ohio, United States
Maumee, Ohio, United States
Toledo, Ohio, United States
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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
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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
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Boise, Idaho, United States
Fargo, North Dakota, United States
Parker, Colorado, United States
Joplin, Missouri, United States
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Grand Island, Nebraska, United States
Fort Smith, Arkansas, United States
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Post Falls, Idaho, United States
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Pekin, Illinois, United States
Fergus Falls, Minnesota, United States
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Lawton, Oklahoma, United States
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Brighton, Michigan, United States
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East China Township, Michigan, United States
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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
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Ontario, Oregon, United States
Cody, Wyoming, United States
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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
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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
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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
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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