Extragonadal Germ Cell TumorPhase 2/3NCT00003643
Combination Chemotherapy in Treating Men With Germ Cell Cancer
A Phase 2/3 study testing bleomycin sulfate, filgrastim and cisplatin in people with Extragonadal Germ Cell Tumor and Teratoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 69 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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer. Read more about this study
- Who is it for?
- Ages 16 to 50 years, men only
- Conditions the study is for
- Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
- What is being tested?
- bleomycin sulfate, filgrastim and cisplatin
- How many people
- 498 participants
- Where
- 69 sitesin 14 countries
- Study dates
- Oct 1998to not given
- Phase
- Phase 2/3
- 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 16 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically proven germ cell cancer
- Seminoma
- Non-seminoma
- Combined
- Intermediate prognosis
- Non-seminoma:
- Testis/retroperitoneal primary
- No non-pulmonary visceral metastases
- Meets 1 of the following criteria:
- Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L
- Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L
- Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)
- Seminoma:
- Any primary site
- Any LDH and HCG
- AFP normal
- Non-pulmonary visceral metastases present
PATIENT CHARACTERISTICS:
Age:
- 16 to 50
Sex:
- Male
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times ULN
- AST no greater than 2 times ULN
Renal:
- Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)
Other:
- No pre-existing neuropathy
- No other malignancy except basal cell skin cancer
- No other serious illness or medical conditions incompatible with the protocol
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
69 sites in 14 countries.
69 sites in 14 countries
Germany20 sites
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200
Universitaetsklinikum Bonn
Bonn, D-53105
St. Johannes Hospital - Medical Klinik II
Duisburg, D-47166
Universitaetsklinikum Essen
Essen, D-45122
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17487
Allgemeines Krankenhaus Hagen
Hagen, D-58095
Universitaetsklinikum Halle
Halle, DOH-06112
University Medical Center Hamburg - Eppendorf
Hamburg, D-20246
Universitaetsklinikum des Saarlandes
Homburg, D-66421
Klinikum Kassel
Kassel, D-34125
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, D-67063
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, D-39120
Klinikum der Stadt Mannheim
Mannheim, D-68135
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, D-35033
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Münster, D-48149
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90419
Klinikum der Universitaet Regensburg
Regensburg, D-93053
Klinikum Schwerin
Schwerin, D-19049
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076
United Kingdom17 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF4 7XL
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Western Infirmary
Glasgow, Scotland, G11 6NT
Gartnavel General Hospital
Glasgow, Scotland, G12 0YN
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Saint Bartholomew's Hospital
London, England, EC1A 7BE
University College Hospital - London
London, England, WC1E 6AU
Christie Hospital
Manchester, England, M20 4BX
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, PR2 9HT
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal South Hants Hospital
Southampton, England, SO14 0YG
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Spain10 sites
Hospital de la Santa Cruz i Sant Pau
Barcelona, 08025
Vall d'Hebron University Hospital
Barcelona, 08035
Institut Catala D'Oncologia
Barcelona, 08907
Hospital Universitario San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Sant Joan de Reus
Reus, 43201
Hospital Universidad Virgen Del Rocio
Seville, E- 41013
Hospital Universitario La Fe
Valencia, 46009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Netherlands7 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Leiden University Medical Center
Leiden, 2300 CA
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, 3000 CA
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
University Medical Center Utrecht
Utrecht, 3584 CX
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
France3 sites
Centre Regional Francois Baclesse
Caen, 14076
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, F-94805
Denmark2 sites
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, DK-8000
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Austria1 site
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, A-1100
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, 02 781
About this study
Official title: Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.
PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
Read the detailed description
OBJECTIVES:
Phase II
- Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
- Define the toxicity profile of T-BEP in these patients.
Phase III
- Compare the disease-free survival of patients treated with these regimens.
- Compare the complete response rates and overall survival of patients treated with these regimens.
- Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
- Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
- Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.
In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.
- Being tested
- bleomycin sulfate, filgrastim, cisplatin, etoposide, paclitaxel
- Keywords
- stage III malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, testicular immature teratoma, testicular mature teratoma
- Medical subject headings
- Teratoma, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma, Endodermal Sinus Tumor, Carcinoma, Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
filgrastimBiological
cisplatinDrug
etoposideDrug
paclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival as measured by Logrank
Secondary outcomes (5)
Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 1998
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ronald De Wit, MD, PhD, Study chair, Daniel Den Hoed Cancer Center at Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003643
- Sponsor's protocol ID
- EORTC-30983
- Other IDs
- EORTC-30983
- Status last verified
- Mar 2012
- First submitted
- 1 Nov 1999
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
- ClinicalTrials.gov ID
- NCT00003643
- Acronym / sponsor ID
- EORTC-30983
- Keywords
- stage III malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Oct 1998
- First posted
- 27 Jan 2003 (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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.
PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
Detailed description
OBJECTIVES:
Phase II
- Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
- Define the toxicity profile of T-BEP in these patients.
Phase III
- Compare the disease-free survival of patients treated with these regimens.
- Compare the complete response rates and overall survival of patients treated with these regimens.
- Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
- Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
- Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.
In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| filgrastim | Biological | – |
| cisplatin | Drug | – |
| etoposide | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Failure-free survival as measured by Logrank
5 secondary outcomes
Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Ronald De Wit, MD, PhD study chair
Daniel Den Hoed Cancer Center at Erasmus Medical Center
69 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bleomycin sulfate, filgrastim and cisplatin in people with Extragonadal Germ Cell Tumor and Teratoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 69 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: status not confirmed, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Germany, United Kingdom, Spain, Netherlands, Belgium 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
Failure-free survival as measured by Logrank. It is what the study was designed to measure, not a finding.
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 6 Mar 2012.