|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Information provided by: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00024141 |
Purpose
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 |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study |
| Study Start Date: | May 2001 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Patrick Creaven, MD, Institutional Review Board |
| ClinicalTrials.gov Identifier: | NCT00024141 History of Changes |
| Other Study ID Numbers: | CDR0000068895, RPCI-RP-01-01 |
| Study First Received: | September 13, 2001 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms Fluorouracil Irinotecan Camptothecin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |