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Home > "P" Clinical Trials Conditions > Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer  Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of combining paclitaxel and carboplatin with or without celecoxib before surgery in treating patients who have stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: - Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib. - Compare the clinical response rate in patients treated with these regimens. - Compare chemotherapy-related toxicity in patients treated with these regimens. - Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection. - Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection. In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months. PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Stage IIIA - Must have N2 disease by mediastinoscopy - Potentially resectable PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding disorder Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and/or ALT less than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No significant history of unstable cardiovascular disease - No inadequately controlled hypertension - No angina - No myocardial infarction within the past 6 months - No ventricular cardiac arrhythmias requiring medication - No congestive heart failure that would preclude study participation Pulmonary - Pulmonary function acceptable for surgery - No interstitial pneumonia - No interstitial fibrosis Gastrointestinal - No bowel obstruction within the past 5 years - No history of peptic ulcer disease - No irritable bowel disease - No inflammatory bowel syndrome - No chronic diarrhea Immunologic - No uncontrolled infection (including HIV) - No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates - No hypersensitivity to paclitaxel Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - No uncontrolled diabetes mellitus - No significant psychiatric illness that would preclude study compliance - No other serious underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No concurrent chronic steroids, except inhaled mometasone or fluticasone Radiotherapy - Not specified Surgery - Not specified Other - At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs) - More than 3 weeks since other prior clinical trial therapy - Concurrent low-dose aspirin (less than 325 mg every other day) for cardiovascular disease prophylaxis allowed - No concurrent NSAIDs, including chronic use - No concurrent cyclo-oxygenase-2 (COX-2) inhibitors - No other concurrent investigational agents - No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital) - No concurrent lithium - No concurrent fluconazole
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Principal Investigator, Jonsson Comprehensive Cancer Center
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Nasser Altorki 212-746-4528
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-5907
United States
Recruiting Robert Figlin 310-794-6501
Additional Information:
Study ID Numbers: CDR0000304540; UCLA-0208074,PHARMACIA-COXAON-0509-106,NYH-CMC-0902-464
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062179
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
2. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
3. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
4. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
5. Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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