Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

Sponsor

Medical Research Council (Other)

Overall Status

Completed

CT.gov ID

NCT00301782

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2010

Outcome Measures

Primary Outcome Measures

Response rates to treatment []

Secondary Outcome Measures

Overall survival []
Progression-free survival []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England	United Kingdom	B15 2TH
2	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
3	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
4	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England	United Kingdom	GL53 7AN
5	Walsgrave Hospital	Coventry	England	United Kingdom	CV2 2DX
6	Royal Devon and Exeter Hospital	Exeter	England	United Kingdom	EX2 5DW
7	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
8	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
9	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
10	University College of London Hospitals	London	England	United Kingdom	WIT 3AA
11	Christie Hospital	Manchester	England	United Kingdom	M20 4BX
12	Clatterbridge Centre for Oncology	Merseyside	England	United Kingdom	CH63 4JY
13	Nottingham City Hospital	Nottingham	England	United Kingdom	NG5 1PB
14	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England	United Kingdom	PR2 9HT
15	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England	United Kingdom	RG1 5AN
16	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
17	Royal Marsden - Surrey	Sutton	England	United Kingdom	SM2 5PT
18	Beatson West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G11 6NT
19	Raigmore Hospital	Inverness	Scotland	United Kingdom	1V2 3UJ
20	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales	United Kingdom	CF14 2TL