Extragonadal Germ Cell TumorPhase 2NCT00002903
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
A Phase 2 study testing docetaxel in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 49 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
- What is being tested?
- docetaxel
- How many people
- 25 participants
- Where
- 49 sitesin 14 countries
- Study dates
- Jul 1995to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
49 sites in 14 countries.
49 sites in 14 countries
France14 sites
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
CHU de la Timone
Marseille, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Institut Curie - Section Medicale
Paris, 75248
Centre Eugene Marquis
Rennes, 35062
Centre Henri Becquerel
Rouen, 76038
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Hopital Paul Brousse
Villejuif, 94804
Institut Gustave Roussy
Villejuif, F-94805
Italy5 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Istituto Europeo Di Oncologia
Milan, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
San Raffaele Hospital
Rome, 00144
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00161
Netherlands5 sites
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1117 MB
Academisch Ziekenhuis Groningen
Groningen, 9713 EZ
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
Rotterdam Cancer Institute
Rotterdam, 3075 EA
Switzerland5 sites
University Hospital
Basel, CH-4031
Ospedale San Giovanni
Bellinzona, CH-6500
Inselspital, Bern
Bern, CH-3010
Clinique De Genolier
Genolier, Ch-1272
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
Germany4 sites
Martin Luther Universitaet
Halle, DOH-0-6112
Universitats-Krankenhaus Eppendorf
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Klinikum Nurnberg
Nuremberg (Nurnberg), D-90419
United Kingdom4 sites
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Royal Marsden NHS Trust
London, England, SW3 6JJ
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Herlev Hospital - University Hospital of Copenhagen
Herlev, DK-2730
Israel2 sites
Rambam Medical Center
Haifa, 31096
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Austria1 site
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, A-1100
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1093
About this study
Official title: 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.
Read the 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.
- Being tested
- docetaxel
- Keywords
- recurrent malignant testicular germ cell tumor, testicular seminoma, recurrent ovarian germ cell tumor, extragonadal germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2004 (estimated)
- Study startJul 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extragonadal Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Emma Geertruida Elisabeth De Vries, MD, PhD, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002903
- Sponsor's protocol ID
- EORTC-16945T
- Other IDs
- EORTC-16945T
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER
- ClinicalTrials.gov ID
- NCT00002903
- Acronym / sponsor ID
- EORTC-16945T
- Keywords
- recurrent malignant testicular germ cell tumor, testicular seminoma, recurrent ovarian germ cell tumor, extragonadal germ cell tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jul 1995
- First posted
- 13 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
Related trials for Extragonadal Germ Cell Tumor
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
RecruitingPhase 2
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Germ Cell Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Geertruida Elisabeth De Vries, MD, PhD study chair
University Medical Center Groningen
49 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 49 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France, Italy, Netherlands, Switzerland, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.