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Trial record 2 of 4 for:    "Cystic Teratoma" | "Antibiotics, Antitubercular"

Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301782
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor Biological: bleomycin sulfate Drug: carboplatin Drug: cisplatin Drug: etoposide phosphate Drug: vincristine sulfate Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
Study Start Date : June 2005
Actual Study Completion Date : June 2010

Primary Outcome Measures :
  1. Response rates to treatment

Secondary Outcome Measures :
  1. Overall survival
  2. Progression-free survival
  3. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301782

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United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Sponsors and Collaborators
Medical Research Council
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Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust

Publications of Results:
Layout table for additonal information Identifier: NCT00301782     History of Changes
Other Study ID Numbers: CDR0000456203
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
testicular mature teratoma
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular yolk sac tumor
testicular yolk sac tumor and teratoma
stage I malignant testicular germ cell tumor
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
recurrent extragonadal non-seminomatous germ cell tumor
stage I extragonadal non-seminomatous germ cell tumor
stage II 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
adult teratoma
Additional relevant MeSH terms:
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Antibiotics, Antineoplastic
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators