Status:
COMPLETED
Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it i...
Detailed Description
OBJECTIVES: Primary * To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and Carboplatin as first-line therapy as assessed by response rate in patients with chemo-naïve ext...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Extensive stage small cell lung cancer
- Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Lesion cannot be from a previously irradiated area
- Lesions that are considered nonmeasurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated area
- No brain metastasis or carcinomatous meningitis unless stable and asymptomatic
- PATIENT CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm³
- Platelet count \> 100,000/mm³
- Serum bilirubin ≤ 1.5 mg/dL
- AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver metastases present)
- Serum creatinine ≤ 2.0 mg/dl
- Hemoglobin ≥ 9.0 g/dl
Exclusion
- CNS metastasis excluded unless: stable and asymptomatic
- Coexisting medical condition that would preclude study compliance
- Patients with Gilbert's disease
- Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or \> 16.6 mmol/L
- Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on study. Gabapentin is permitted
- Patients who do not discontinue St. John's Wort prior to first treatment dose on study.
- Patients who are pregnant or breast feeding
- Concomitant second active malignancy except for any in situ cancer or adequately treated basal cell or squamous cell skin cancer or any cancer from which the patients has been disease-free for at least 2 years
- No administration of any prior systemic anticancer therapy for extensive stage SCLC such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents. Concurrent use of other anticancer therapy including inhibitors of vascular endothelial or epidermal growth factor pathways is prohibited. Prior radiation is allowed
- Symptomatic brain metastasis or carcinomatous meningitis
- PRIOR CONCURRENT THERAPY:
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00469898
Start Date
December 1 2003
End Date
July 1 2010
Last Update
July 27 2012
Active Locations (8)
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1
Owensboro Medical Health System
Owensboro, Kentucky, United States, 42303
2
Memorial Health Care System
Chattanooga, Tennessee, United States, 37404
3
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
4
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37901