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

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00453232

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor	Biological: bleomycin sulfate Biological: pegfilgrastim Drug: cisplatin Drug: etoposide	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

Toxicity []
Feasibility []

Secondary Outcome Measures

Response rate []
Progression-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
2	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
3	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
4	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE4 6BE
5	Churchill Hospital	Oxford	England	United Kingdom	OX3 7LJ
6	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland	United Kingdom	EH4 2XU
7	Beatson West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G11 6NT