Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

This study has been completed.
Information provided by:
Roswell Park Cancer Institute Identifier:
First received: September 13, 2001
Last updated: March 3, 2011
Last verified: March 2011

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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: May 2001
Study Completion Date: January 2003
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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.
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  RPCI-RP-01-01 
Study First Received: September 13, 2001
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on May 26, 2016