Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
- Conditions
- Germ Cell Tumor
- Registration Number
- NCT00127049
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 37
-
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.
- Patients infected by the human immunodeficiency virus (HIV)
- Patients who do not fit inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method Toxicity Progression free survival Overall survival
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France