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Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer



Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

For Condition: stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Yale Cancer Center , 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. PURPOSE: Phase II trial to study the effectiveness of paclitaxel and irinotecan in treating patients who have advanced non-small cell lung cancer.
Details: OBJECTIVES: - Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer. OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists - Stage IIIB with pleural effusion allowed - Measurable or evaluable disease - CNS metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver) Renal: - Creatinine clearance at least 70 mL/min Other: - No other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective birth control - No active infection - No concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior systemic chemotherapy for lung cancer - No prior irinotecan or paclitaxel Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior wide field radiotherapy - No prior radiotherapy to greater than 20% of bone marrow allowed Surgery: - See Disease Characteristics - Recovered from prior surgery
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnMurren,  Study Chair,  Yale Cancer Center

Northwestern Connecticut Oncology-Hematology Associates *Recruiting*
Torrington,  Connecticut,  06790
United States
Recruiting Debra  Brandt 860-482-5384

Yale Comprehensive Cancer Center *Recruiting*
New Haven,  Connecticut,  06520-8028
United States
Recruiting John  Murren 203-785-4191


Additional Information:
Study ID Numbers:  CDR0000067608;  YALE-HIC-10740,NCI-G00-1701
Study Start Date: 
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004924

Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer

2. Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

3. Paclitaxel in Treating Patients With Lung Cancer

4. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

5. Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

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Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
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