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Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer Clinical research trials and Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare available for their Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer  Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,adenosquamous cell lung cancer,Quality of Life,adenocarcinoma of the lung,squamous cell lung cancer,large cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: This study will accrue 600 patients over 2 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerioLilenbaum, Study Chair, Cancer and Leukemia Group B
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Additional Information:
Study ID Numbers: CDR0000065871; CLB-9730
Study Start Date: October 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003117
Other Large Cell Lung Cancer Studies:
1. Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Paclitaxel in Treating Patients With Lung Cancer
3. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
4. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
5. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Related Studies:
Other large cell lung cancer Clinical Trials
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Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
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