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Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

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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)

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 13, 2006
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Response rates to treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00301782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Overall survival
  • Progression-free survival
  • Toxicity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
Official Title  ICMJE Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • Biological: bleomycin sulfate
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: etoposide phosphate
  • Drug: vincristine sulfate
Study Arms  ICMJE Not Provided
Publications * Huddart RA, Gabe R, Cafferty FH, Pollock P, White JD, Shamash J, Cullen MH, Stenning SP; TE23 Trial Management Group and Collaborators; National Cancer Research Institute Testis Cancer Clinical Studies Group. A randomised phase 2 trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP in poor-prognosis germ cell tumours (MRC TE23, CRUK 05/014, ISRCTN 53643604). Eur Urol. 2015 Mar;67(3):534-43. doi: 10.1016/j.eururo.2014.06.034. Epub 2014 Jul 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
88
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301782
Other Study ID Numbers  ICMJE CDR0000456203
MRC-TE23
EU-205107
ISRCTN53643604
EUDRACT-2004-000405-22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical Research Council
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date May 2007

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