Overview

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNICANCER
Treatments:
Bleomycin
Cisplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Oxaliplatin
Paclitaxel
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the
following criteria:

- Histologically confirmed NSGCT

- Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or
alpha-fetoprotein (AFP) levels

- Clinical stage II-III disease (disseminated disease)

- Testicular, retroperitoneal, or mediastinal primary site

- Poor prognosis disease, meeting 1 of the following criteria:

- Mediastinal primary site

- Non-pulmonary visceral metastases

- One of the following lab values:

- HCG > 50,000 UI/L

- AFP > 10,000 ng/mL

- Lactate dehydrogenase > 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age

- Over 16

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times ULN

Renal

- Creatinine clearance > 60 mL/min

Other

- No other prior malignancy except basal cell skin cancer

- No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified