Overview

Combination Chemotherapy In Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
2007-08-01
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 combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Calcium
Gemcitabine
Leucovorin
Levoleucovorin
Tegafur
Criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignancy refractory to existing
chemotherapy or for which no standard therapy exists

- Evaluable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Greater than 3 months

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm3

- Platelet count greater than 100,000/mm3

- Hemoglobin greater than 8.0 mg/dL

Hepatic:

- Bilirubin less than 2.0 mg/dL

- AST less than 3.0 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- No active infection requiring antibiotics

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil)
and recovered

- No prior gemcitabine

Endocrine therapy:

- Prior hormonal therapy allowed

- No concurrent hormonal contraception

Radiotherapy:

- At least 3 weeks since prior radiotherapy to large areas of active bone marrow and
recovered

Surgery:

- Prior major surgery allowed and recovered

Other:

- No prior or concurrent antiviral nucleosides