Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer, Carcinoma, Small Cell, SCLC
Both
Small Cell Lung Cancer, Carcinoma, Small Cell, SCLC
Trial Information
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1: Maximum Tolerated Dose
Outcome Time Frame:
every cycle
Safety Issue:
Yes
Principal Investigator
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
11089
NCT ID:
NCT00447421
Start Date:
February 2007
Completion Date:
May 2008
Related Keywords:
- Small Cell Lung Cancer
- Carcinoma, Small Cell
- SCLC
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
Name | Location |
|---|
