Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and
capecitabine when given in combination with a fixed dose of oxaliplatin in patients
with advanced solid tumors.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the antitumor response of these patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan and capecitabine.
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30
minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days
1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or
chemotherapy
- Bidimensionally measurable or evaluable disease
- No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT less than 2 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No known hypersensitivity to fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and
recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior large-field radiotherapy and recovered
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
Outcome Time Frame:
Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity.
Safety Issue:
Yes
Principal Investigator
Scot C. Remick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU5Y99
NCT ID:
NCT00006465
Start Date:
December 2000
Completion Date:
April 2005
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
