Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002903
• Other study ID #: EORTC-16945T
• Secondary ID: EORTC-16945T
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: July 1995

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extragonadal Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann - Institute for Applied Cancer Research	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital - University Hospital of Copenhagen	Herlev
France	Institut Bergonie	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Institut Curie - Section Medicale	Paris
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Hopital Paul Brousse	Villejuif
France	Institut Gustave Roussy	Villejuif
Germany	Martin Luther Universitaet	Halle Saale
Germany	Universitats-Krankenhaus Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum Nurnberg	Nuremberg (Nurnberg)
Greece	University of Ioannina	Ioannina
Israel	Rambam Medical Center	Haifa
Israel	Schneider Children's Medical Center of Israel	Petah-Tikva
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Istituto Europeo Di Oncologia	Milano
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	San Raffaele Hospital	Rome
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	University Hospital	Basel
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Inselspital, Bern	Bern
Switzerland	Clinique De Genolier	Genolier
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Royal Marsden NHS Trust	London	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

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