Clinical trial NCT00453232: Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Official title: Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extragonadal Germ Cell Tumor
Teratoma
Testicular Germ Cell Tumor
Keywords: stage III 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 malignant testicular germ cell tumor
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-28
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Toxicity
measure: Feasibility
Secondary outcomes:
measure: Response rate
measure: Progression-free survival
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: England
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: England
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre at Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Scotland
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Michael Williams, MD
role: STUDY_CHAIR
References: