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

NCT ID: NCT00001495

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-11-30
• Study Completion Date: 2000-10-31

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.

Conditions

Neoplasms

Study Design

• Primary Study Purpose: TREATMENT

Interventions

irinotecan (CPT-11)

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Locations

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 1653362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8044782 (View on PubMed)

Other Identifiers

96-C-0013

Identifier Type: -

Identifier Source: secondary_id

960013

Identifier Type: -

Identifier Source: org_study_id