Clinical Trial: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

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 Summary:

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.

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: November 1, 1999
Date Started: July 1995
Date Completion:
Last Updated: June 29, 2012
Last Verified: June 2012