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| Descriptive Information Fields | |
| Brief Title † | A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors |
| Official Title † | A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors |
| 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 Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Neoplasms |
| Intervention † | Drug: irinotecan (CPT-11) |
| MEDLINE PMIDs | 1653362, 8044782 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 40 |
| Start Date † | November 1995 |
| Completion Date | October 2000 |
| Eligibility 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00001495 |
| Organization ID | 960013 |
| Secondary IDs †† | 96-C-0013 |
| Study Sponsor † | National Cancer Institute (NCI) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | September 1999 |
| First Received Date † | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
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