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	Treatment or Intervention	Phase
recurrent testicular cancer recurrent ovarian germ cell tumor testicular seminoma extragonadal germ cell tumor	Drug: docetaxel	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Emma Geertruida Elisabeth De Vries,  Study Chair,  EORTC Early Clinical Studies Group   

Study ID Numbers:  CDR0000065251; EORTC-16945T
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002903
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08