Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Gemcitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer

• Metastatic disease

• Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm

• Not a candidate for anthracycline or taxane chemotherapy

• No brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Life expectancy > 12 weeks

• Neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Alkaline phosphatase < 5 times upper limit of normal (ULN)

• Bilirubin < 1.5 times ULN

• Creatinine < 1.5 times ULN OR creatinine clearance > 30 mL/min

• SGOT and SGPT < 3 times ULN (5 times ULN if liver metastases present)

• No pre-existing neuropathy

• Not pregnant or nursing

• No uncontrolled hypercalcemia

• No familial, social, geographical, or psychological condition that would preclude study treatment

• No other malignancy that is not considered cured

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic disease, including anthracyclines or taxanes

• Prior hormonal therapy allowed