Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

March 3, 2011 updated by: Roswell Park Cancer Institute

5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
  • Determine the toxic effects of this regimen in these patients.
  • Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
  • Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value
  • Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST less than 2 times ULN
  • Alkaline phosphatase less than 2 times ULN
  • Lactic dehydrogenase less than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • HIV negative
  • No active uncontrolled bacterial, viral, or fungal infection
  • No nonmalignant systemic disease that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior irinotecan

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control
  • No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture)

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior major surgery

Other:

  • No concurrent anticoagulants except warfarin or subcutaneous heparin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ramnath N, Creaven PJ, Khushalani N, et al.: Pilot studies of antimetabolites preceeded by irinotecan in advanced solid tumors. [Abstract] Eur J Cancer 38 (Suppl 7): S44-5, 2002.
  • Creaven PJ, Slocum HK, Toth K, et al.: Modulation of 5-fluorouracil by irinotecan in advanced solid tumors: a pilot study. [Abstract] Int J Cancer 100 (Suppl 13): A-O78, 94, 2002.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

September 1, 2002

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

June 19, 2003

First Posted (Estimate)

June 20, 2003

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068895
  • RPCI-RP-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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