Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: oxaliplatin; Drug: irinotecan hydrochloride; Drug: capecitabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006465

U01CA062502 (U.S. NIH Grant/Contract)

CWRU5Y99

CWRU-5Y99 (Other Identifier)

NCI-370

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)