Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000537042 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2004-000847-79 | |||
| EU-20713 | |||
| ISRCTN18505589 | Registry Identifier | ISRCTN (International Standard Randomised Controlled Trial Number Register) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| pegfilgrastim | Biological | |||
| cisplatin | Drug | |||
| etoposide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | ||
| Feasibility |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ||
| Progression-free survival |
Not provided
DISEASE CHARACTERISTICS:
Patients must fulfill all of the following criteria for 1 of the following diagnoses:
Nonseminoma germ cell tumor (intermediate risk)
Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
Seminoma (intermediate prognosis)
Surveillance relapse
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Williams, MD | Cambridge University Hospitals NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital | Cambridge | England | CB2 2QQ | United Kingdom | ||
| Leeds Cancer Centre at St. James's University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Leeds |
| England |
| LS9 7TF |
| United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Churchill Hospital | Oxford | England | OX3 7LJ | United Kingdom |
| Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| ID | Term |
|---|---|
| D013724 | Teratoma |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| D018239 | Seminoma |
| D018236 | Carcinoma, Embryonal |
| D018240 | Endodermal Sinus Tumor |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D018237 | Germinoma |
| D008649 | Mesonephroma |
Not provided
Not provided
| ID | Term |
|---|---|
| D001761 | Bleomycin |
| C455861 | pegfilgrastim |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
Not provided
Not provided