5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
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 Institute | Buffalo, New York 14263 |
