Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

NCT ID: NCT00002903

Last Updated: 2012-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma Geertruida Elisabeth De Vries, MD, PhD

Role: STUDY_CHAIR

University Medical Center Groningen

Locations

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Ludwig Boltzmann - Institute for Applied Cancer Research

Vienna, , Austria

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Herlev Hospital - University Hospital of Copenhagen

Herlev, , Denmark

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

CHU de la Timone

Marseille, , France

Site Status

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Site Status

Institut Curie - Section Medicale

Paris, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Hopital Paul Brousse

Villejuif, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Martin Luther Universitaet

Halle, , Germany

Site Status

Universitats-Krankenhaus Eppendorf

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Klinikum Nurnberg

Nuremberg (Nurnberg), , Germany

Site Status

University of Ioannina

Ioannina, , Greece

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Site Status

Istituto Europeo Di Oncologia

Milan, , Italy

Site Status

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, , Italy

Site Status

San Raffaele Hospital

Rome, , Italy

Site Status

Istituti Fisioterapici Ospitalieri - Roma

Rome, , Italy

Site Status

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

Site Status

University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Site Status

Norwegian Radium Hospital

Oslo, , Norway

Site Status

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, , Portugal

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

University Hospital

Basel, , Switzerland

Site Status

Ospedale San Giovanni

Bellinzona, , Switzerland

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Clinique De Genolier

Genolier, , Switzerland

Site Status

Kantonsspital - Saint Gallen

Sankt Gallen, , Switzerland

Site Status

Royal Marsden NHS Trust

London, England, United Kingdom

Site Status

Newcastle General Hospital

Newcastle upon Tyne, England, United Kingdom

Site Status

Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, Scotland, United Kingdom

Site Status

Countries

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Austria Belgium Denmark France Germany Greece Israel Italy Netherlands Norway Portugal Spain Switzerland United Kingdom

Other Identifiers

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EORTC-16945T

Identifier Type: -

Identifier Source: secondary_id

EORTC-16945T

Identifier Type: -

Identifier Source: org_study_id

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