A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
N/A
N/A
Both
Neoplasms
Trial Information
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
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.
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 0-2.
Hematopoietic: AGC greater than 1,500.
Platelets greater than 100,000.
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.
OTHER:
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
960013
NCT ID:
NCT00001495
Start Date:
November 1995
Completion Date:
October 2000
Related Keywords:
- Neoplasms
- Camptothecin
- Cancer
- Chemotherapy
- Natural Products
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| National Cancer Institute (NCI) | Bethesda, Maryland 20892 |
