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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Amgen
Baxter Healthcare Corporation
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00231582
First received: October 3, 2005
Last updated: February 24, 2011
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Testicular Neoplasms
 Drug: epirubicin
Procedure: high-dose and autologous stem cell transplantation
Drug: paclitaxel
Drug: etoposide
Drug: ifosfamide
Drug: carboplatin
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Complete response rate


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: September 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1
 Drug: epirubicin
epirubicin
Other Name: epirubicin
Procedure: high-dose and autologous stem cell transplantation
high-dose and autologous stem cell transplantation
Other Name: high-dose and autologous stem cell transplantation
Drug: paclitaxel
paclitaxel
Other Name: paclitaxel
Drug: etoposide
etoposide
Other Name: etoposide
Drug: ifosfamide
ifosfamide
Other Name: ifosfamide
Drug: carboplatin
carboplatin
Other Name: carboplatin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligibility requirements includes the following criteria:

  • Age >18 years and < 65
  • Performance status < 3
  • Histologically or biologically documented GCTs
  • Testicular, abdominal, or mediastinal tumors
  • Measurable or evaluable disease
  • Life expectancy > 3 months
  • Normal cardiac, liver, and renal function tests
  • Absence of infection
  • HIV negative test
  • Signed informed consent
  • All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT

Exclusion Criteria:

  • Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)
  • Relapses after complete answer obtained by surgery ( sCR )
  • Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn
  • Antecedents of congestive even compensated cardiac insufficiency
  • Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens
  • Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231582

Locations
France
Hôpital TENON, Service d'Oncologie Médicale
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Amgen
Baxter Healthcare Corporation
Investigators
Principal Investigator: Jean-Pierre LOTZ, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Isabelle Brindel, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00231582     History of Changes
Other Study ID Numbers: P031101
Study First Received: October 3, 2005
Last Updated: February 24, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
High-dose with autologous germ-cell tumors

Additional relevant MeSH terms:
Neoplasms
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Epirubicin
Etoposide phosphate
Isophosphamide mustard
 Etoposide
Ifosfamide
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 22, 2013