Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

NCT00301782 | Completed Phase 2

• 5 other identifiers: CDR0000456203MRC-TE23EU-205107ISRCTN53643604EUDRACT-2004-000405-22
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 20

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.

Conditions

Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Keywords

testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma; testicular yolk sac tumor; testicular yolk sac tumor and teratoma; 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; testicular immature teratoma; testicular mature teratoma; adult teratoma

Outcome Measures

Primary Outcomes (1)

• Response rates to treatment

Secondary Outcomes (3)

• Overall survival

• Progression-free survival

• Toxicity

Interventions

bleomycin sulfate BIOLOGICAL

carboplatin DRUG

cisplatin DRUG

etoposide phosphate DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (20)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (1)

• Huddart RA, Gabe R, Cafferty F, et al.: A randomized phase II trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP in poor prognosis germ cell tumors (MRC TE23, CRUK 05/014, ISRCTN53643604). [Abstract] J Clin Oncol 29 (Suppl 15): A-4508, 2011.

  RESULT

MeSH Terms

Conditions

Teratoma; Testicular Germ Cell Tumor; Carcinoma, Embryonal; Endodermal Sinus Tumor; Testicular Neoplasms

Interventions

Bleomycin; Carboplatin; Cisplatin; etoposide phosphate; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Mesonephroma; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Robert A. Huddart, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: June 1, 2005
• Study Completion: June 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2007-05

Locations

GB (20)