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| ID | Type | Description | Link |
|---|---|---|---|
| 96-C-0013 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan (CPT-11) | Drug |
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1653362 | Background | Negoro S, Fukuoka M, Masuda N, Takada M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Niitani H, Taguchi T. Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst. 1991 Aug 21;83(16):1164-8. doi: 10.1093/jnci/83.16.1164. | |
| 8044782 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Marty ME, Mathieu-Boue A. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994 Aug 15;54(16):4347-54. |