High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II
High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach.
Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy) poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12 g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).
This phase II study is designed as a Gehan method. The main objective of the study is the complete response rate. With this aim in view, it is planned to enroll in its first step 14 patients to insure that if no complete response (CR) is noticed, study would be stopped for inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol specified that up to 45 patients will be included in order to reduce the confidence interval (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate. The statistical analysis is done in terms of intent-to-treat.
Procedure: high-dose and autologous stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sequential High-Dose Chemotherapy Combining Two Mobilization and Cyto-Reductive Treatments Followed by Three High-Dose Chemotherapy Regimens Supported by Autologous Stem Cell Transplantation|
- Complete response rate [ Time Frame: during de study ] [ Designated as safety issue: Yes ]Complete response rate
- Survival (overall and progression-free), toxicity, toxic-death rate. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Survival (overall and progression-free), toxicity, toxic-death rate.
|Study Start Date:||September 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Other Name: epirubicinProcedure: high-dose and autologous stem cell transplantation
high-dose and autologous stem cell transplantation
Other Name: high-dose and autologous stem cell transplantationDrug: paclitaxel
Other Name: paclitaxelDrug: etoposide
Other Name: etoposideDrug: ifosfamide
Other Name: ifosfamideDrug: carboplatin
Other Name: carboplatin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00231582
|Hôpital TENON, Service d'Oncologie Médicale|
|Paris, France, 75020|
|Principal Investigator:||Jean-Pierre LOTZ, Pr,MD,PhD||Assistance Publique - Hôpitaux de Paris|