Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Part of paid clinical trials in Lewes, Delaware.
- Sponsor
- Eastern Cooperative Oncology Group
- Study ID
- NCT00057837
- Phase
- PHASE2
- Status
- Completed
Conditions
- Extensive Stage Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- G-CSF — BIOLOGICALG-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery \> 10,000 dL.
- Cisplatin — DRUGArm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.
- Etoposide — DRUGArm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.
- Irinotecan — DRUG50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).
- Topotecan — DRUGTopotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).
Study Details
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 in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Key Dates
- Start date
- Jul 14, 2004
- Status verified
- Jun 2023
- Primary completion
- Jan 31, 2012
- Completion
- Aug 31, 2012
Study Design
- Enrollment
- 140 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PET (Topotecan/Etoposide/Cisplatin/G-CSF)Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
- Experimental: PIE (Irinotecan/Cisplatin/Etoposide)Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
Primary Outcome Measure
Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST) [ Time Frame: Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry. ]
Locations (79)
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