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

Unicancer

Status and phase: Completed; Phase 3

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

Treatments: Drug: oxaliplatin; Biological: bleomycin sulfate; Drug: paclitaxel; Drug: cisplatin; Drug: etoposide; Drug: ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00104676

GETUG 13

FRE-FNCLCC-GETUG-13/0206 (Other Identifier)

2005-001072-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.
• Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive 3 additional courses of BEP.
• Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.

Enrollment: 263 patients

Sex: All

Ages: 16 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

Arm I

Active Comparator group

Description:

Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).

Treatment:

Drug: etoposide

Drug: cisplatin

Biological: bleomycin sulfate

Arm II

Experimental group

Description:

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

Treatment:

Drug: ifosfamide

Drug: etoposide

Drug: cisplatin

Drug: paclitaxel

Biological: bleomycin sulfate

Drug: oxaliplatin