Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1995

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 12, 2004

First Posted (Estimate)

May 13, 2004

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16945T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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