Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00024141
First received: September 13, 2001
Last updated: March 3, 2011
Last verified: March 2011
  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 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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024141

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

Additional Information:
Publications:
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
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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 23, 2014