High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II

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.

Conditions

• Testicular Neoplasms

Interventions

DRUG

epirubicin

epirubicin

PROCEDURE

high-dose and autologous stem cell transplantation

high-dose and autologous stem cell transplantation

DRUG

paclitaxel

paclitaxel

DRUG

etoposide

etoposide

DRUG

ifosfamide

ifosfamide

DRUG

carboplatin

carboplatin

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• Amgen

  collaborator INDUSTRY

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jean-Pierre LOTZ, Pr,MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-09-30

Primary Completion

2010-01-31

Completion

2010-01-31

Countries

• France

Study Locations