- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301782
Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating germ cell tumors.
PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ cell tumors treated with intensive induction chemotherapy comprising cisplatin, vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and cisplatin (BEP) vs standard BEP chemotherapy.
Secondary
- Compare overall and progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to participating center, pre-protocol low-dose chemotherapy (yes vs no), and other clinically important factors. Patients are randomized to 1 of 2 treatment arms.
- Arm I (BEP): Patients receive bleomycin IV over 15 minutes once on day 1 or 2 and days 8 and 15 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (CBOP/BEP): Patients receive chemotherapy according to the following schedule:
- Weeks 1-6: Patients receive cisplatin IV over 6 hours on days 1, 2, 8, 15, 16, and 22 (OR over 4 hours on days 1-5 and 15-19); vincristine IV on days 1, 8, 15, 22, 29, and 36; bleomycin IV over 15 minutes on days 1, 15, 29, and 36 and bleomycin IV continuously on days 8-12 and 22-25; and carboplatin IV over 30-60 minutes on days 8 and 22.
- Weeks 7-15: Patients receive bleomycin IV continuously on days 1-5, 8-12, and 15-19 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for 4 courses.
After completion of study treatment, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
-
Birmingham, England, United Kingdom, B15 2TH
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
-
Bristol, England, United Kingdom, BS2 8ED
- Bristol Haematology and Oncology Centre
-
Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
-
Cheltenham, England, United Kingdom, GL53 7AN
- Gloucestershire Oncology Centre at Cheltenham General Hospital
-
Coventry, England, United Kingdom, CV2 2DX
- Walsgrave Hospital
-
Exeter, England, United Kingdom, EX2 5DW
- Royal Devon and Exeter Hospital
-
Leeds, England, United Kingdom, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
-
Leicester, England, United Kingdom, LE1 5WW
- Leicester Royal Infirmary
-
London, England, United Kingdom, EC1A 7BE
- Saint Bartholomew's Hospital
-
London, England, United Kingdom, WIT 3AA
- University College of London Hospitals
-
Manchester, England, United Kingdom, M20 4BX
- Christie Hospital
-
Merseyside, England, United Kingdom, CH63 4JY
- Clatterbridge Centre for Oncology
-
Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital
-
Preston, England, United Kingdom, PR2 9HT
- Rosemere Cancer Centre at Royal Preston Hospital
-
Reading, England, United Kingdom, RG1 5AN
- Berkshire Cancer Centre at Royal Berkshire Hospital
-
Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
-
Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden - Surrey
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G11 6NT
- Beatson West of Scotland Cancer Centre
-
Inverness, Scotland, United Kingdom, 1V2 3UJ
- Raigmore Hospital
-
-
Wales
-
Cardiff, Wales, United Kingdom, CF14 2TL
- Velindre Cancer Center at Velindre Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:
- Histologic confirmation
- Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) > 5,000 IU/L with appropriate clinical picture in a man < 45 years of age
Poor prognosis features as defined by ≥ 1 of the following:
- AFP > 10,000 ng/mL
- hCG > 50,000 IU/L
- Lactic dehydrogenase > 10 times normal
- Nonpulmonary visceral metastases
- Mediastinal primary site
PATIENT CHARACTERISTICS:
- Male
- WHO performance status 0-3
Glomerular filtration rate > 50 mL/min
- Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy
- No comorbid condition that would prevent treatment
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rates to treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Progression-free survival
|
Overall survival
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert A. Huddart, MD, Royal Marsden NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage II malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- recurrent malignant testicular germ cell tumor
- adult teratoma
- testicular embryonal carcinoma
- testicular choriocarcinoma
- testicular yolk sac tumor
- testicular embryonal carcinoma and teratoma
- testicular embryonal carcinoma and yolk sac tumor
- testicular yolk sac tumor and teratoma
- testicular choriocarcinoma and yolk sac tumor
- testicular choriocarcinoma and embryonal carcinoma
- testicular choriocarcinoma and teratoma
- recurrent extragonadal non-seminomatous germ cell tumor
- stage III extragonadal non-seminomatous germ cell tumor
- stage IV extragonadal non-seminomatous germ cell tumor
- recurrent extragonadal germ cell tumor
- testicular immature teratoma
- testicular mature teratoma
- stage I malignant testicular germ cell tumor
- stage I extragonadal non-seminomatous germ cell tumor
- stage II extragonadal non-seminomatous germ cell tumor
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Testicular Neoplasms
- Teratoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Carboplatin
- Etoposide
- Etoposide phosphate
- Vincristine
- Bleomycin
Other Study ID Numbers
- CDR0000456203
- MRC-TE23
- EU-205107
- ISRCTN53643604
- EUDRACT-2004-000405-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Testicular Germ Cell Tumor
-
N.N. Petrov National Medical Research Center of...RecruitingTesticular Germ Cell TumorRussian Federation
-
Royal Marsden NHS Foundation TrustUniversity College London (UCL) Cancer InstituteUnknownTesticular Germ Cell TumorUnited Kingdom
-
National Cancer Institute (NCI)TerminatedTesticular Seminoma | Recurrent Ovarian Germ Cell Tumor | Stage II Ovarian Germ Cell Tumor | Stage III Ovarian Germ Cell Tumor | Ovarian Dysgerminoma | Recurrent Malignant Testicular Germ Cell Tumor | Stage II Malignant Testicular Germ Cell Tumor | Stage III Malignant Testicular Germ Cell TumorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Yolk Sac Tumor | Recurrent Ovarian Germ Cell Tumor | Recurrent Childhood Malignant Germ Cell Tumor | Recurrent Malignant Testicular Germ Cell Tumor | Childhood Extracranial Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | Ovarian... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Teratoma | Stage II Malignant Testicular Germ Cell Tumor | Stage III Malignant Testicular Germ Cell Tumor | Childhood Embryonal Tumor | Childhood Extracranial Germ Cell Tumor | Childhood Extragonadal Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
European Organisation for Research and Treatment...CompletedTesticular Germ Cell Tumor | Unspecified Adult Solid Tumor, Protocol SpecificFrance, Netherlands, Norway, Belgium, Switzerland, Austria, United Kingdom, Germany, Denmark
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Eastern Cooperative Oncology Group; Southwest... and other collaboratorsCompletedTesticular Germ Cell Tumor | Extragonadal Germ Cell Tumor | Childhood Germ Cell TumorUnited States, Puerto Rico, Australia, Peru
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Seminoma | Testicular Yolk Sac Tumor | Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | Ovarian Embryonal Carcinoma | Ovarian Yolk Sac Tumor | Testicular Embryonal Carcinoma | Ovarian Choriocarcinoma | Ovarian Mixed Germ Cell Tumor | Testicular Choriocarcinoma and other conditionsUnited States
-
University of Texas Southwestern Medical CenterActive, not recruitingTesticular Germ Cell Tumor | Testicular Neoplasms | Testicular Diseases | Testis Cancer | Testicular Cancer | Germ Cell Tumor | Testicular Yolk Sac Tumor | Testicular Choriocarcinoma | Germ Cell Tumor of Testis | Germ Cell Tumor, Testicular, Childhood | Germ Cell Cancer Metastatic | Germ Cell Neoplasm of Retroperitoneum and other conditionsUnited States
-
European Organisation for Research and Treatment...UnknownTesticular Germ Cell Tumor | Teratoma | Extragonadal Germ Cell TumorFrance, Netherlands, Spain, United Kingdom, Norway, Belgium, Germany, Denmark, Hungary, Slovakia, Israel, Italy, Austria, Poland
Clinical Trials on carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Eli Lilly and CompanyCompletedLung NeoplasmsUnited States
-
AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina