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Search / Trial NCT00004137

S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer

Launched by SWOG CANCER RESEARCH NETWORK · Apr 9, 2004

Trial Information

Current as of June 18, 2025

Completed

Keywords

Extensive Stage Small Cell Lung Cancer

ClinConnect Summary

OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinue...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically or cytologically proven, previously untreated extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR Previously treated with radiotherapy and/or surgery Measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present
  • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is in complete remission
  • PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and recovered

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

Oklahoma City, Oklahoma, United States

Tucson, Arizona, United States

Los Angeles, California, United States

Los Angeles, California, United States

Orange, California, United States

Denver, Colorado, United States

Lexington, Kentucky, United States

Jackson, Mississippi, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Sacramento, California, United States

Wichita, Kansas, United States

San Antonio, Texas, United States

Phoenix, Arizona, United States

Atlanta, Georgia, United States

Kansas City, Missouri, United States

Maywood, Illinois, United States

Detroit, Michigan, United States

Long Beach, California, United States

Los Angeles, California, United States

Martinez, California, United States

Oakland, California, United States

Santa Rosa, California, United States

Travis Air Force Base, California, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

Jamaica Plain, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Springfield, Missouri, United States

Billings, Montana, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Portland, Oregon, United States

Greenville, South Carolina, United States

Seattle, Washington, United States

Albuquerque, New Mexico, United States

Temple, Texas, United States

Honolulu, Hawaii, United States

Cleveland, Ohio, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Denver, Colorado, United States

Fort Gordon, Georgia, United States

Decatur, Illinois, United States

Hines, Illinois, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Southfield, Michigan, United States

Biloxi, Mississippi, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

San Antonio, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Phoenix, Arizona, United States

Kansas City, Kansas, United States

New Orleans, Louisiana, United States

Grand Rapids, Michigan, United States

Keesler Afb, Mississippi, United States

Fort Sam Houston, Texas, United States

Lubbock, Texas, United States

Salt Lake City, Utah, United States

Galveston, Texas, United States

Ann Arbor, Michigan, United States

Mobile, Alabama, United States

Kansas City, Kansas, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Portland, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Frank Dunphy, MD

Study Chair

Duke Cancer Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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