Status:
COMPLETED
Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irin...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- Stage IIIA or IIIB disease
- Progressive disease
- Stage IV disease
- Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
- Measurable or evaluable disease, as defined by 1 of the following criteria:
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
- Lesions apparent on CT scan that do not meet the criterion for measurability
- Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- More than 12 weeks
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- AST and ALT ≤ 1.5 times normal
- Alkaline phosphatase \< 1.5 times normal
- Bilirubin ≤ 1.3 mg/dL
- Renal
- Creatinine ≤ 1.6 mg/dL OR
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past 3 months
- No life-threatening ventricular arrhythmia requiring maintenance therapy
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- No uncontrolled seizure disorder
- No uncontrolled diabetes mellitus
- No active infection requiring systemic therapy
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other unstable or serious condition
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy
- Prior irinotecan allowed
- No prior gemcitabine
- No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- More than 1 month since prior participation in another clinical trial using an investigational agent
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00182806
Start Date
September 1 2004
End Date
July 1 2008
Last Update
March 6 2012
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001