Overview

This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments gemcitabine hydrochloride, oxaliplatin
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date August 2005
Trial size 45 participants
Trial identifier NCT00274859, CDR0000454320, EU-20571, GERCOR-SEGEMOX-S04-1, LILLY-GERCOR-SEGEMOX-S04-1, SANOFI-GERCOR-SEGEMOX-S04-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Objective response rate
time frame:

Secondary Outcomes

Measure
Clinical benefit
time frame:
Tolerability
time frame:
Progression-free
time frame:
Overall survival
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).