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

NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Teratoma; Extragonadal Germ Cell Tumor; Testicular Germ Cell Tumor

Treatments: Drug: etoposide; Drug: cisplatin; Biological: bleomycin sulfate; Biological: pegfilgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00453232

CDR0000537042 (Registry Identifier)

EUDRACT-2004-000847-79

CRCA-CCTC-ACCELERATED-BEP

EU-20713

ISRCTN18505589 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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