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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
N/A
N/A
Not Enrolling
Both
Neoplasms

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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


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