A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Recurrent or metastatic cancer, including lymphoma.
- •No leukemia.
- •No active CNS disease.
- •Refractory to all effective therapy OR No effective therapy exists.
- •Measurable disease not required.
- •PRIOR/CONCURRENT THERAPY:
- •Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy.
- •Chemotherapy: Greater than 4 weeks and recovered from chemotherapy.
- •Previous therapy with irinotecan is permitted.
- •Endocrine Therapy: Not specified.
- •Radiotherapy: Greater than 4 weeks since radiotherapy.
- •Surgery: Recovered from prior surgery.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: ECOG 0-
- •Hematopoietic: AGC greater than 1,
- •Platelets greater than 100,
- •Hepatic: Bilirubin no greater than 1.5 mg/dL.
- •AST no greater than 2 times normal.
- •Renal: Creatinine no greater than 1.5 mg/dL.
- •HIV negative.
- •No active infection requiring antibiotics.
- •No concurrent medical illness that would interfere with chemotherapy.
- •No pregnant or nursing women.
- •Adequate contraception required of fertile patients.
- •Imaging/exams for tumor measurement within 28 days prior to registration.
Exclusion Criteria
- Not provided