Status:
UNKNOWN
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Gi...
Detailed 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....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00274859
Start Date
August 1 2005
Last Update
July 24 2008
Active Locations (14)
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1
C.H.G. Beauvais
Beauvais, France, 60021
2
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France, 25030
3
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, France, 62200
4
Centre Jean Perrin
Clermont-Ferrand, France, 63011