Lung Cancer Clinical Trial

Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.

PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.

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Full Description

OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

4

Study ID:

NCT00003917

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

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There are 53 Locations for this study

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University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix Arizona, 85012, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley California, 92708, United States
Scripps Clinic
La Jolla California, 92037, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles California, 90073, United States
Southwest Cancer Care
Poway California, 92064, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Sidney Kimmel Cancer Center
San Diego California, 92121, United States
Oncology Clinic, P.C.
Colorado Springs Colorado, 80909, United States
Shands Cancer Center
Gainesville Florida, 32610, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Oncology-Hematology Group of South Florida
Miami Florida, 33176, United States
Baptist Hospital- Pensacola
Pensacola Florida, 32522, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Medical College of Georgia Hospital and Clinics
Augusta Georgia, 30912, United States
Evanston Northwestern Health Care
Evanston Illinois, 60201, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Oncology and Hematology Associates, Inc.
Indianapolis Indiana, 46219, United States
Louisiana Oncology Associates
Lafayette Louisiana, 70506, United States
Alton Ochsner Medical Foundation Hospital
New Orleans Louisiana, 70121, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
St. Joseph Mercy Hospital
Pontiac Michigan, 48341, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
St. John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
Cooper Cancer Institute
Camden New Jersey, 08103, United States
St. Barnabas Medical Center
Livingston New Jersey, 07039, United States
Cooper Hospital/University Medical Center
Voorhees New Jersey, 08043, United States
Santa Fe Hematology/Oncology
Santa Fe New Mexico, 87505, United States
Rochester General Hospital
Rochester New York, 14621, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Salem Research
Winston-Salem North Carolina, 27103, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Penn State Geisinger Cancer Center
Hershey Pennsylvania, 17033, United States
Central Pennsylvania Hematology & Medical Oncology Associates, PC
Lemoyne Pennsylvania, 17043, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Brown University Oncology Group
Providence Rhode Island, 02912, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States
Spartanburg Regional Healthcare System
Spartanburg South Carolina, 29303, United States
Baptist Regional Cancer Center - Knoxville
Knoxville Tennessee, 37901, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville Tennessee, 37203, United States
Texas Cancer Care
Fort Worth Texas, 76104, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
Scott and White Memorial Hospital
Temple Texas, 76508, United States
Office of Michael E. Lee
Norfolk Virginia, 23502, United States
Hematology & Oncology Associates of Virginia
Richmond Virginia, 23226, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

4

Study ID:

NCT00003917

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

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