High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Amgen Baxter Healthcare Corporation Ministry of Health, France