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Trial record 4 of 18 for:    "Teratoma" | "Anti-Bacterial Agents"

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.
 
ClinicalTrials.gov Identifier: NCT00301782
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : August 26, 2013
Sponsor:
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:

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.

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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00301782


Locations
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Sponsors and Collaborators
Medical Research Council
Investigators
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Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00301782    
Other Study ID Numbers: CDR0000456203
MRC-TE23
EU-205107
ISRCTN53643604
EUDRACT-2004-000405-22
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 choriocarcinoma and teratoma
testicular embryonal carcinoma and teratoma
testicular yolk sac tumor and teratoma
testicular immature teratoma
testicular mature teratoma
adult teratoma
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular yolk sac tumor
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
Additional relevant MeSH terms:
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Teratoma
Antibiotics, Antineoplastic
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
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
Carboplatin
Etoposide
Vincristine
Bleomycin
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