Lung Cancer Clinical Trial

Paclitaxel With or Without Carboplatin in Treating Patients With Advanced 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: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV non-small cell lung cancer.

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Full Description

OBJECTIVES: I. Compare the overall survival of patients with non-small cell lung cancer treated with paclitaxel alone or in combination with carboplatin. II. Compare the quality of life of these patients treated with these chemotherapy regimens. III. Compare the response rates and the toxic effects of the two regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to stage of disease (stage IIIB vs stage IV vs recurrent or progressive after surgery and/or radiotherapy), performance status (0-1 vs 2), and age (under 70 vs 70 and over). Patients are randomized to one of two treatment arms. Arm I receives paclitaxel IV over 3 hours on day 1 of each course. Arm II receives paclitaxel as in Arm I, followed by carboplatin IV over 1 hour. Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2, 6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months until disease progression or death.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer (adenocarcinoma, large cell, squamous cell, or mixture) Stage IIIB due to any of the following: Malignant pleural effusion Supraclavicular node involvement Contralateral hilar node involvement Not eligible for CALGB protocols of combined therapy and chest irradiation Stage IV Any stage that has recurred or progressed after surgery or radiotherapy Measurable or evaluable disease Does not include the following: Bone metastases Pleural or peritoneal effusions Irradiated lesions, unless progression documented after radiation therapy No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times the upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Other: No prior or concurrent malignancy except: Curatively treated carcinoma in situ of the cervix Curatively treated breast cancer Curatively treated basal cell or squamous cell skin cancer At least 5 years since any nonrecurrent primary tumor surgically resected without administration of adjuvant radiation therapy or chemotherapy HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or dexamethasone Radiotherapy: At least 2 weeks since prior radiotherapy See Disease Characteristics Surgery: Prior surgery allowed See Disease Characteristics

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

584

Study ID:

NCT00003117

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 30 Locations for this study

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University of California San Diego Cancer Center
La Jolla California, 92093, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
University of Illinois at Chicago Health Sciences Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13210, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38103, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Massey Cancer Center
Richmond Virginia, 23298, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

584

Study ID:

NCT00003117

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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