Lung Cancer Clinical Trial

Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.

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Full Description

OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than 1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT00003900

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 19 Locations for this study

See Locations Near You

CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Siouxland Hematology-Oncology
Sioux City Iowa, 51101, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CentraCare Clinic
Saint Cloud Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
Quain & Ramstad Clinic, P.C.
Bismarck North Dakota, 58501, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Altru Health Systems
Grand Forks North Dakota, 58201, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
Saskatchewan Cancer Agency
Regina Saskatchewan, S4S 6, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT00003900

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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