Status:
UNKNOWN
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Germ Cell Tumor
Eligibility:
MALE
16+ years
Phase:
PHASE2
Brief Summary
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis...
Eligibility Criteria
Inclusion
- Patients older than 16 years
- Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
- Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:
- Testicular primary site
- Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
- Either a complete response or a partial response with normal serum AFP and HCG
- Relapse documented by rising AFP and/or HCG or by a biopsy
- No previous carcinoma, except basal-cell carcinoma of the skin
- Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
- Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubin \< 1.5 fold the upper normal value
- Signed informed consent.
Exclusion
- Patients infected by the human immunodeficiency virus (HIV)
- Patients who do not fit inclusion criteria
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00127049
Start Date
December 1 2004
Last Update
September 8 2006
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805