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PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER


Phase 2
18 Years
N/A
Not Enrolling
Both
Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed extragonadal and gonadal germ cell tumor
Seminoma and nonseminoma eligible Recurrent or refractory disease despite adequate
first-line cisplatin- or carboplatin-based chemotherapy and not amenable to surgery and/or
curative radiotherapy Relapse after disease-free interval of 1 or more years ineligible
Measurable or evaluable disease with documented progression within 2 months prior to entry
Elevated beta human chorionic gonadotropin and alpha-fetoprotein considered evaluable if
no other evaluable lesion and provided marker(s): Increased since end of last treatment At
least 10 times upper limit of normal unless due to tumor lysis Rising on 3 successive
occasions at least 2-3 days apart If no tumor markers available, cytology or histology
should be obtained No inadequately treated CNS metastases No pleural or pericardial
effusion and/or ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal AST/ALT no
greater than 3 times normal Alkaline phosphatase no greater than 2.5 times normal Renal:
Creatinine no greater than 1.6 mg/dL Creatinine clearance at least 60 mL/min if creatinine
borderline (1.1-1.6 mg/dL) Other: No active infection No severe malnutrition No
pre-existing grade 2 or worse neurotoxicity No pre-existing edema No senility or psychosis
No other expected difficulties for follow-up including geographic considerations No other
malignancy except: Second testicular primary tumor Treated basocellular and planocellular
skin carcinoma Adequately treated carcinoma in situ of the cervix Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior high dose chemotherapy with or without stem cell transplant At
least 3 weeks since chemotherapy and past WBC and platelet nadirs Endocrine therapy: Not
specified Radiotherapy: Not amenable to curative radiotherapy At least 3 weeks since
radiotherapy and recovered Surgery: Not amenable to surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Emma Geertruida Elisabeth De Vries, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Medical Centre Groningen

Authority:

United States: Federal Government

Study ID:

EORTC-16945T

NCT ID:

NCT00002903

Start Date:

July 1995

Completion Date:

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • testicular seminoma
  • recurrent ovarian germ cell tumor
  • extragonadal germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

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