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Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2007
Sponsored by: Cambridge University Hospitals NHS Foundation Trust
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00453232
  Purpose

RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.

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.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Teratoma
Testicular Germ Cell Tumor
Biological: bleomycin
Biological: pegfilgrastim
Drug: cisplatin
Drug: etoposide
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Bleomycin Cisplatin Etoposide Pegfilgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Feasibility [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2004
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453232

Locations
United Kingdom, England
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Michael Williams, MD     44-122-321-7020     michael.williams@addenbrookes.nhs.uk    
Churchill Hospital Recruiting
Oxford, England, United Kingdom, OX3 7LJ
Contact: Andrew Protheroe, MD     44-1865-226-185        
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: John Chester     44-113-243-3144        
Northern Centre for Cancer Treatment at Newcastle General Hospital Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Contact: Rhona McMenemin     44-191-219-4200        
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Jonathan Shamash, MD, FRCP     44-207-601-7221     jonathan.shamash@bartsandthelondon.nhs.uk    
United Kingdom, Scotland
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    
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Grahame Howard, MD     44-131-537-3270        
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
Study Chair: Michael Williams, MD Cambridge University Hospitals NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000537042, CRCA-CCTC-ACCELERATED-BEP, EUDRACT-2004-000847-79, EU-20713
Study First Received: March 27, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00453232  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
testicular choriocarcinoma and seminoma
testicular embryonal carcinoma and seminoma
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma
testicular choriocarcinoma and yolk sac tumor
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular seminoma
testicular yolk sac tumor
testicular yolk sac tumor and teratoma with seminoma
testicular yolk sac tumor and teratoma
recurrent extragonadal non-seminomatous germ cell tumor
recurrent extragonadal seminoma
stage IV extragonadal non-seminomatous germ cell tumor
stage IV extragonadal seminoma
adult teratoma
testicular immature teratoma
testicular mature teratoma
recurrent extragonadal germ cell tumor

Study placed in the following topic categories:
Choriocarcinoma
Seminoma
Nonseminomatous germ cell tumor
Testicular Neoplasms
Etoposide phosphate
Bleomycin
Recurrence
Carcinoma
Cisplatin
Neoplasms, Germ Cell and Embryonal
Testicular cancer
Teratoma
Etoposide
Extragonadal Germ Cell Tumor

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2009