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Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002903
  Purpose

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.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: July 1995
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002903

  Hide Study Locations
Locations
Austria
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, Austria, A-1100
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Denmark
Herlev Hospital - University Hospital of Copenhagen
Herlev, Denmark, DK-2730
Rigshospitalet
Copenhagen, Denmark, 2100
France
Centre Leon Berard
Lyon, France, 69373
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre Eugene Marquis
Rennes, France, 35062
Centre Henri Becquerel
Rouen, France, 76038
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Centre Oscar Lambret
Lille, France, 59020
CHU de la Timone
Marseille, France, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Hopital Paul Brousse
Villejuif, France, 94804
Institut Bergonie
Bordeaux, France, 33076
Institut Claudius Regaud
Toulouse, France, 31052
Institut Curie - Section Medicale
Paris, France, 75248
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Klinikum Nurnberg
Nuremberg (Nurnberg), Germany, D-90419
Martin Luther Universitaet
Halle Saale, Germany, DOH-0-6112
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Greece
University of Ioannina
Ioannina, Greece, GR-45110
Israel
Rambam Medical Center
Haifa, Israel, 31096
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
San Raffaele Hospital
Rome, Italy, 00144
Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6252 HB
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Portugal
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Inselspital, Bern
Bern, Switzerland, CH-3010
Kantonsspital - Saint Gallen
Saint Gallen, Switzerland, CH-9007
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
University Hospital
Basel, Switzerland, CH-4031
United Kingdom, England
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
United Kingdom, Scotland
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Emma Geertruida Elisabeth De Vries, MD, PhD University Medical Centre Groningen
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065251, EORTC-16945T
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002903     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent malignant testicular germ cell tumor
testicular seminoma
recurrent ovarian germ cell tumor
extragonadal germ cell tumor

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Docetaxel
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009