Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical Research Council
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301782
First received: March 9, 2006
Last updated: August 30, 2011
Last verified: May 2007
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Vincristine sulfate
Bleomycin sulfate
Bleomycin
Sulfate ion
Cisplatin
Etoposide
Carboplatin
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rates to treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 88 |
| Study Start Date: | June 2005 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301782
Locations
| United Kingdom | |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting |
| Birmingham, England, United Kingdom, B15 2TH | |
| Contact: Contact Person 44-121-472-1311 | |
| Bristol Haematology and Oncology Centre | Recruiting |
| Bristol, England, United Kingdom, BS2 8ED | |
| Contact: Contact Person 44-117-928-3074 | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Michael Williams, MD 44-1223-217-020 michael.williams@addenbrookes.nhs.uk | |
| Gloucestershire Oncology Centre at Cheltenham General Hospital | Recruiting |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Contact: J.R. Owen, MD 44-84-5422-4021 roger.owen@glos.nhs.uk | |
| Walsgrave Hospital | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: Contact Person 44-24-7660-2020 | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, England, United Kingdom, EX2 5DW | |
| Contact: Anne Hong, MD 44-39-240-2118 anne.hong@rdeft.nhs.uk | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Johnathan Joffe, MD 44-113-206-4184 | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, England, United Kingdom, LE1 5WW | |
| Contact: Albert Benghiat, MD 44-116-258-5081 albert.benghiat@uhl-tr.nhs.uk | |
| University College of London Hospitals | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Stephen J. Harland, MD 44-20-7380-9041 stephen.harland@uclh.org | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Contact Person 44-20-7601-8391 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Richard Welch, MD 44-161-446-3833 | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Peter Clark, MD 44-151-482-7828 peter.clark@ccotrust.nhs.uk | |
| Nottingham City Hospital | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Michael Sokal 44-115-969-1169 | |
| Rosemere Cancer Centre at Royal Preston Hospital | Recruiting |
| Preston, England, United Kingdom, PR2 9HT | |
| Contact: Alison Birtle, MD 44-177-252-2916 alison.birtle@lthtr.nhs.uk | |
| Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting |
| Reading, England, United Kingdom, RG1 5AN | |
| Contact: Paul Rogers, MD 44-118-987-7688 | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Graham M. Mead, MD 44-23-8079-8639 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Contact: Jeff White, MD 44-141-211-6364 jeff.white@northglasgow.scot.nhs.uk | |
| Raigmore Hospital | Recruiting |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| Contact: Contact Person 44-1463-704-000 ext. 4310 | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Contact: Contact Person 44-29-2031-6292 | |
Sponsors and Collaborators
Medical Research Council
Investigators
| Study Chair: | Robert A. Huddart, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00301782 History of Changes |
| Other Study ID Numbers: | CDR0000456203, MRC-TE23, EU-205107, ISRCTN53643604, EUDRACT-2004-000405-22 |
| Study First Received: | March 9, 2006 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Teratoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Bleomycin Etoposide phosphate Cisplatin Etoposide Vincristine Carboplatin Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013