Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00274859|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 11, 2006
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: gemcitabine hydrochloride Drug: oxaliplatin||Phase 2|
- Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2005|
- Objective response rate
- Clinical benefit
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274859
|Beauvais, France, 60021|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Centre Hospitalier Docteur Duchenne|
|Boulogne Sur Mer, France, 62200|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Montfermeil, France, 93370|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Centre Hospitalier de Saint-Quentin|
|Saint-Quentin, France, 02321|
|Senlis, France, 60309|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer|
|Toulon - Cedex, France, 83056|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Joseph Gligorov, MD||Hopital Tenon|