Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
NCT ID: NCT00453232
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2004-08-31
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
* Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.
Secondary
* Determine the response rate in patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bleomycin sulfate
pegfilgrastim
cisplatin
etoposide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must fulfill all of the following criteria for 1 of the following diagnoses:
* Nonseminoma germ cell tumor (intermediate risk)
* Testis or retroperitoneal primary
* Abnormal markers (alpha fetoprotein \[AFP\] \> 1,000 and \< 10,000 ng/mL, human chorionic gonadotropin \[HCG\] \> 5,000 and \< 50,000 IU/L, lactate dehydrogenase \[LDH\] \> 1.5 times and \< 10 times upper limit of normal \[ULN\])
* No liver, bone, brain, or other nonpulmonary visceral metastasis
* Histologic confirmation is not required if AFP or HCG are grossly elevated
* Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
* Mediastinal primary
* Nonpulmonary visceral metastases
* Poor markers (AFP \> 10,000 ng/mL, HCG \> 50,000 IU/L, LDH \> 10 times ULN)
* Histologic confirmation not required if AFP or HCG are grossly elevated
* Seminoma (intermediate prognosis)
* Histological confirmation is required
* Any primary site
* Nonpulmonary visceral metastases must be present
* Normal AFP
* Any HCG
* Any LDH
* Surveillance relapse
* Must fulfill appropriate criteria above according to initial histology
PATIENT CHARACTERISTICS:
* Neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
* No prior malignancy except basal cell carcinoma
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy
18 Years
40 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cambridge University Hospitals NHS Foundation Trust
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Williams, MD
Role: STUDY_CHAIR
Cambridge University Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000537042
Identifier Type: REGISTRY
Identifier Source: secondary_id
EUDRACT-2004-000847-79
Identifier Type: -
Identifier Source: secondary_id
EU-20713
Identifier Type: -
Identifier Source: secondary_id
ISRCTN18505589
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRCA-CCTC-ACCELERATED-BEP
Identifier Type: -
Identifier Source: org_study_id