A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
- Conditions
- Neoplasms
- Registration Number
- NCT00001495
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.
- Detailed Description
Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
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)
National Cancer Institute (NCI)
🇺🇸Bethesda, Maryland, United States
National Cancer Institute (NCI)🇺🇸Bethesda, Maryland, United States