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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001495 |
Purpose
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.
| Condition | Intervention | Phase |
|
Neoplasms |
Drug: irinotecan (CPT-11) |
Phase I |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Camptothecin |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 1995 |
| Estimated Study Completion Date: | October 2000 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 960013, 96-C-0013 |
| First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001495 |
| Health Authority: | United States: Federal Government |
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