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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 30 Locations for this study
La Jolla California, 92093, United States
San Francisco California, 94115, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20307, United States
Miami Beach Florida, 33140, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38103, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23298, United States
Richmond Virginia, 23298, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.