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Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer Clinical research trials and Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer. Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer  Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology 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. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.
Details: OBJECTIVES: - Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin. - Compare the toxicities of each of these 2 regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only. Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes: - Squamous cell - Adenocarcinoma - Large cell anaplastic - Bronchioalveolar - Non-small cell carcinoma not otherwise specified - No small cell anaplastic elements allowed - Must have: - Recurrent disease after prior radiotherapy or surgery OR - Stage IV disease with distant metastases OR - Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray - Bidimensionally measurable or evaluable disease - Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No uncontrolled high blood pressure, unstable angina, or congestive heart failure - No myocardial infarction within the past 6 months - No serious ventricular arrhythmias requiring medication Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other active malignancies requiring ongoing treatment - No uncontrolled serious active infections - No suspected hypersensitivity to agents that utilize Cremophor - No evidence of neuropathy grade 2 or greater by history or physical examination PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for non-small cell lung cancer Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology - Recovered from prior radiotherapy - No concurrent radiotherapy except for whole brain radiation for developing brain metastases Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Westmead Hospital
Westmead, New South Wales, 2145
Australia
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
San Juan City Hospital
San Juan, , 00936-7344
Puerto Rico
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
United States
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
United States
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
Mercy Medical Center
Des Moines, Iowa, 50314
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Additional Information:
Study ID Numbers: CDR0000068012; E-1599
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006004
Other Non-Small Cell Lung Cancer Studies:
1. Study to evaluate the safety and effect of pertuzumab in patients with advanced non-small cell lung cancer, which has progressed after prior chemotherapy
2. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
3. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
4. Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma
5. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Nebraska Clinical Trials
Other Papillion Clinical Trials
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
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