Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase: Unknown; Phase 2

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: gemcitabine hydrochloride; Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00274859

CDR0000454320

EU-20571

LILLY-GERCOR-SEGEMOX-S04-1

GERCOR-SEGEMOX-S04-1

SANOFI-GERCOR-SEGEMOX-S04-1

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

• Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.

Secondary

• Determine the clinical benefit and tolerability of this regimen in these patients.
• Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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