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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024141 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: irinotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Patrick J. Creaven, MBBS, PhD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000068895, RPCI-RP-01-01 |
Study First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024141 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Antimetabolites Immunologic Factors Fluorouracil Irinotecan |
Antineoplastic Agents, Phytogenic Immunosuppressive Agents Camptothecin |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Irinotecan Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Camptothecin Pharmacologic Actions Fluorouracil Therapeutic Uses Antineoplastic Agents, Phytogenic |