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A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors

Phase 1
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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


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.


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.


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.


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:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

November 1995

Completion Date:

October 2000

Related Keywords:

  • Neoplasms
  • Camptothecin
  • Cancer
  • Chemotherapy
  • Natural Products
  • Neoplasms
  • Neoplasms



National Cancer Institute (NCI) Bethesda, Maryland  20892