Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

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. Identifier: NCT00024141
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : March 7, 2011
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: fluorouracil Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
Study Start Date : May 2001
Actual Primary Completion Date : September 2002
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • 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


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


  • 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)


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


  • No concurrent anticoagulants except warfarin or subcutaneous heparin

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 identifier (NCT number): NCT00024141

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Study Chair: Patrick J. Creaven, MBBS, PhD Roswell Park Cancer Institute

Publications of Results:
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.

Other 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.

Responsible Party: Patrick Creaven, MD, Institutional Review Board Identifier: NCT00024141     History of Changes
Other Study ID Numbers: CDR0000068895
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs