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Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical research trials and Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery. Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery clinical trial. Subjects frequently get the best healthcare possible for their Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery  Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
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): Christie Hospital N.H.S. Trust ,
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 paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.
Details: OBJECTIVES: I. Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy. II. Compare the toxic effects of these two regimens in this patient population. III. Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs 3). Patients are randomized to one of two treatment arms: Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30 minutes on day 1. Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on day 1. Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed inoperable advanced non-small cell lung cancer - Stage IIIA, IIIB, or IV - Not eligible for curative radiotherapy or surgery Measurable or evaluable disease - No bony lesions as only site of measurable disease No symptomatic brain metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: See Disease Characteristics --Patient Characteristics-- Age: Over 18 Performance status: ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: At least 12 weeks Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant - Fertile patients must use effective contraception during and for 3 months after study - No active infection - No other serious systemic disorder that would preclude compliance - No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer - No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NickThatcher, Study Chair, Christie Hospital N.H.S. Trust
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067562; CHNT-PC/MIC,EU-99046
Study Start Date: January 1999
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004887
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
2. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
4. Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
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