PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER
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.
Primary Purpose: Treatment
Emma Geertruida Elisabeth De Vries, MD, PhD
University Medical Centre Groningen
United States: Federal Government