Overview

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Capecitabine
Irinotecan
Oxaliplatin
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