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Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Clinical research trials and Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer  Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
For Condition: recurrent ovarian germ cell tumor,extragonadal germ cell tumor,recurrent testicular cancer,testicular seminoma
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EmmaElisabeth De Vries, Study Chair, EORTC Early Clinical Studies Group
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Istituto Europeo Di Oncologia
Milano, , 20141
Italy
Schneider Children's Medical Center of Israel
Petah-Tikva, , 49202
Israel
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
University Hospital
Basel, , CH-4031
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
San Raffaele Hospital
Rome, , 00144
Italy
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Centre Henri Becquerel
Rouen, , 76038
France
University of Ioannina
Ioannina, , GR-45110
Greece
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Centre Oscar Lambret
Lille, , 59020
France
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
Institut Bergonie
Bordeaux, , 33076
France
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Clinique De Genolier
Genolier, , Ch-1272
Switzerland
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , 1093
Portugal
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, , A-1100
Austria
Centre Leon Berard
Lyon, , 69373
France
Rigshospitalet
Copenhagen, , 2100
Denmark
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Institut Claudius Regaud
Toulouse, , 31052
France
CHU de la Timone
Marseille, , 13385
France
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Martin Luther Universitaet
Halle Saale, , DOH-0-6112
Germany
Centre Eugene Marquis
Rennes, , 35062
France
Hopital Paul Brousse
Villejuif, , 94804
France
Rambam Medical Center
Haifa, , 31096
Israel
Institut Curie - Section Medicale
Paris, , 75248
France
Additional Information:
Study ID Numbers: CDR0000065251; EORTC-16945T
Study Start Date: July 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002903
Other Recurrent Testicular Cancer Studies:
1. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
2. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
3. Arsenic Trioxide in Treating Men With Germ Cell Cancer
4. Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
Related Studies:
Other recurrent testicular cancer Clinical Trials
Other Clinical Trials
Other Genolier Clinical Trials
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
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