Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
Condition: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Testicular Neoplasms
Intervention: bleomycin sulfate; cisplatin; etoposide; ifosfamide; oxaliplatin; paclitaxel
Intervention description: At least one course administered; At least one course administered; At least one course administered; Given in a dose-dense sequential fashion; Given in a dose-dense sequential fashion; Given in a dose-dense sequential fashion
Intervention MeSH terms: Paclitaxel; Etoposide; Oxaliplatin; Ifosfamide; Bleomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 3 trial with direct individual benefit, randomized, open-label, multicenter, parallel groups
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 16 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II malignant testicular germ cell tumor; stage III malignant testicular germ cell tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor; stage II extragonadal non-seminomatous germ cell tumor; stage III extragonadal non-seminomatous germ cell tumor; testicular immature teratoma; testicular mature teratoma; adult teratoma

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.
    

Eligibility 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