Combination Chemotherapy in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Pathologically proven advanced cancer for which no curative therapy exists

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 9 g/dL

Hepatic:

• Bilirubin normal

• SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

• Creatinine normal

Other:

• Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition

• No concurrent medical condition that is likely to interfere with study participation

• No active visual disturbances that require intervention beyond corrective lenses

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow transplantation

• No concurrent immunotherapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No prior high dose chemotherapy with bone marrow or stem cell rescue

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormone therapy (except megestrol acetate)

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to 25% or more of bone marrow

• No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study)

Surgery:

• Not specified

Other:

• At least 30 days since prior investigational therapy

• No concurrent investigational therapy