Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301782
First received: March 9, 2006
Last updated: August 23, 2013
Last verified: May 2007

March 9, 2006
August 23, 2013
June 2005
Not Provided
Response rates to treatment [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00301782 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
  • Biological: bleomycin sulfate
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: etoposide phosphate
  • Drug: vincristine sulfate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
June 2010
Not Provided

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
Male
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00301782
CDR0000456203, MRC-TE23, EU-205107, ISRCTN53643604, EUDRACT-2004-000405-22
Not Provided
Not Provided
Medical Research Council
Not Provided
Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP