A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.
Phase 1
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00034502
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Histologic or cytologic diagnosis of locally or metastatic colorectal cancer
- Prior therapy with 5-FU for metastatic cancer
- Adequate bone marrow, liver and kidney function
Exclusion Criteria
- Pregnancy
- Breast feeding
- Inability to interrupt aspirin therapy
- Brain metastasis
- Patients who have been treated previously with ALIMTA or irinotecan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
🇩🇪Munchen, Germany