|
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Clinical research trials and Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer. Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer  Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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 whether carboxyamidotriazole is more effective than no further treatment for non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with stage III or IV non-small cell lung cancer treated with oral carboxyamidotriazole (CAI) vs placebo. - Evaluate the safety and tolerability of oral CAI in these patients. - Compare the time to disease progression in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Determine the response rate of patients with measurable or evaluable disease treated with CAI. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to timing of first-line therapy (prior to registration vs after registration), disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral carboxyamidotriazole daily. - Arm II: Patients receive oral placebo daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then monthly during study. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 750 patients (375 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage III or IV non-small cell lung cancer (NSCLC) - Received or plan to receive 1 and only 1 chemotherapy regimen with or without thoracic radiotherapy as first-line therapy for NSCLC - Disease must be stable or responding after prior or planned chemotherapy for 3-6 months - No untreated brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months (patients who have received first-line therapy) OR - At least 6 months (patients who plan to receive first-line therapy) Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal: - Creatinine no greater than 1.5 times ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No other concurrent immunotherapy Chemotherapy: - See Disease Characteristics - Prior radiosensitizers allowed - No more than 6 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No more than 6 weeks since prior thoracic radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - No concurrent participation in another phase III lung cancer treatment trial
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, Mayo Clinic Cancer Center
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
California Cancer Center
Fresno, California, 93720
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Altru Cancer Center
Grand Forks, North Dakota, 58201
United States
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
Additional Information:
Study ID Numbers: CDR0000067033; NCCTG-972451,CTSU
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003869
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
2. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
3. Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
5. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Minnesota Clinical Trials
Other St. Cloud Clinical Trials
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
|
|
|
|
|
|
|
|
