Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

Testicular Germ Cell Tumor Clinical Trial

Official title:

Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301782
• Other study ID #: CDR0000456203
• Secondary ID: MRC-TE23EU-20510
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2006
• Last updated: August 23, 2013
• Start date: June 2005
• Est. completion date: June 2010

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• bleomycin sulfate

Drug:
• carboplatin

• cisplatin

• etoposide phosphate

• vincristine sulfate

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 induct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates to treatment			No
Secondary	Overall survival			No
Secondary	Progression-free survival			No
Secondary	Toxicity			Yes