Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit |  |  | 
| Tolerability |  |  | 
| Progression-free |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific