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

September 13, 2001
March 3, 2011
May 2001
September 2002   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00024141 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2003
September 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024141
CDR0000068895, RPCI-RP-01-01
Yes
Patrick Creaven, MD, Institutional Review Board
Roswell Park Cancer Institute
Not Provided
Study Chair: Patrick J. Creaven, MBBS, PhD Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP