NCT00447421
Terminated
Phase 1
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- pemetrexed
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Phase 1: Maximum Tolerated Dose
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Measurable disease with diagnosis of Small Cell Lung Cancer.
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
- •Patients must be at least 18 years of age and have at least a 12-week life expectancy.
- •No prior chemotherapy and/or prior thoracic radiotherapy.
- •Adequate pulmonary function and organ function.
Exclusion Criteria
- •Patients with myocardial infarction within the preceding six months.
- •Diagnosis of a serious concomitant systemic disorder.
- •Prior radiotherapy to the lower neck or abdominal region.
- •Significant weight loss.
- •Concurrent administration of any other antitumor therapy.
Arms & Interventions
A
Intervention: pemetrexed
A
Intervention: cisplatin
A
Intervention: radiation
Outcomes
Primary Outcomes
Phase 1: Maximum Tolerated Dose
Time Frame: every cycle
Phase 2: Overall Response Rate
Time Frame: baseline to measured progressive disease
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
Secondary Outcomes
- Phase 1: Best Overall Response(baseline to measured response)
- Phase 2: Complete Response Rate(baseline to measured response time)
- Phase 2: Time to Progressive Disease(baseline to measured progressive disease)
- Phase 2: Duration of Response(time of response to progressive disease)
- Phase 2: Overall Survival(baseline to date of death from any cause)
Study Sites (1)
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