Medpedia

Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

Active, not recruiting
07/01/1995 to Present
25
Phase 2
Interventional

Conditions

  • Extragonadal Germ Cell Tumor
  • Ovarian cancer
  • Testicular Germ Cell Tumor

Eligibility

18 and older
No
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

Purpose

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.

Interventions

  • Drug: docetaxel

Officials

  • Emma Geertruida Elisabeth De Vries, MD, PhD
    Study Chair, University Medical Centre Groningen

Locations

  • Beatson Oncology Centre
    Glasgow, Scotland, G11 6NT, United Kingdom
    Active, not recruiting
  • Western General Hospital
    Edinburgh, Scotland, EH4 9NQ, United Kingdom
    Active, not recruiting
  • Newcastle General Hospital
    Newcastle Upon Tyne, England, NE4 6BE, United Kingdom
    Active, not recruiting
  • Royal Marsden NHS Trust
    London, England, SW3 6JJ, United Kingdom
    Active, not recruiting
  • Kantonsspital - Saint Gallen
    Saint Gallen, CH-9007, Switzerland
    Active, not recruiting
  • Clinique De Genolier
    Genolier, Ch-1272, Switzerland
    Active, not recruiting
  • Inselspital, Bern
    Bern, CH-3010, Switzerland
    Active, not recruiting
  • Ospedale San Giovanni
    Bellinzona, CH-6500, Switzerland
    Active, not recruiting
  • University Hospital
    Basel, CH-4031, Switzerland
    Active, not recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
    Active, not recruiting
  • Instituto Portugues de Oncologia de Francisco Gentil
    Lisbon, 1093, Portugal
    Active, not recruiting
  • Norwegian Radium Hospital
    Oslo, N-0310, Norway
    Active, not recruiting

Sponsors

  • European Organization for Research and Treatment of Cancer
    Lead Sponsor
  • United States: Federal Government

Links

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