Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
décembre 2004
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI, Dr | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- 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 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