Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

Phase 2

Completed

• Conditions: Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor

• Registration Number: NCT00002903
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.

Detailed Description

OBJECTIVES: I. Determine whether partial or complete responses can be achieved with docetaxel (TXT) in patients with recurrent or refractory disseminated germ cell cancer previously treated with standard-dose chemotherapy. II. Assess the probability of actual response warranting further evaluation of the therapeutic effectiveness of TXT in the case that partial or complete tumor responses are achieved in this patient population. III. Characterize further the toxic effects of TXT in these patients.

OUTLINE: Patients receive intravenous docetaxel over 1 hour every 3 weeks until disease progression, unacceptable toxicity, or at least 3 courses beyond documentation of complete response. Patients may receive concurrent radiotherapy provided not all indicator lesions are included in irradiated field. Resection of residual mature teratoma is allowed no sooner than 8 weeks after therapy provided tumor markers are normalized for at least 4 weeks.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-12
• Study First Posted: 2004-05-13
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (49)

Ludwig Boltzmann - Institute for Applied Cancer Research; 🇦🇹 Vienna, Austria

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Herlev, Denmark

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

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