A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
- Conditions
- Small Cell Lung CancerCarcinoma, Small CellSCLC
- Interventions
- Registration Number
- NCT00447421
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A radiation - A pemetrexed - A cisplatin -
- Primary Outcome Measures
Name Time Method Phase 1: Maximum Tolerated Dose every cycle Phase 2: Overall Response Rate 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 Outcome Measures
Name Time Method Phase 1: Best Overall Response baseline to measured response 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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Phase 2: Complete Response Rate baseline to measured response time Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
Phase 2: Time to Progressive Disease baseline to measured progressive disease Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Phase 2: Duration of Response time of response to progressive disease The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Phase 2: Overall Survival baseline to date of death from any cause Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇳🇱Rotterdam, Netherlands