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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001495
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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.

Condition Intervention Phase
Neoplasms Drug: irinotecan (CPT-11) Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: November 1995
Estimated Study Completion Date: October 2000
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001495


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001495     History of Changes
Other Study ID Numbers: 960013
96-C-0013
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: September 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Camptothecin
Cancer
Chemotherapy
Natural Products
Neoplasms

Additional relevant MeSH terms:
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action