Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

Testicular Germ Cell Tumor Clinical Trial

Official title:

Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453232
• Other study ID #: CRCA-CCTC-ACCELERATED-BEP
• Secondary ID: CDR0000537042EUD
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: August 6, 2013
• Start date: August 2004
• Est. completion date: January 2009

Study information

• Verified date: August 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• bleomycin sulfate

• pegfilgrastim

Drug:
• cisplatin

• etoposide

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
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

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity			Yes
Primary	Feasibility			No
Secondary	Response rate			No
Secondary	Progression-free survival			No