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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick J. Creaven, MBBS, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068895

NCT ID:

NCT00024141

Start Date:

May 2001

Completion Date:

January 2003

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263