Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
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ClinicalTrials.gov Identifier: NCT00127049
Recruitment Status : Unknown
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Genital Diseases, Male
Endocrine System Diseases