Clinical trial NCT00470366
Conditions: Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor
Keywords: stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and seminoma 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 and teratoma with seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor stage I malignant testicular germ cell tumor adult central nervous system germ cell tumor ovarian choriocarcinoma ovarian dysgerminoma ovarian embryonal carcinoma ovarian yolk sac tumor ovarian immature teratoma ovarian mature teratoma ovarian monodermal and highly specialized teratoma ovarian polyembryoma ovarian mixed germ cell tumor stage IV ovarian germ cell tumor stage IV extragonadal seminoma stage I extragonadal non-seminomatous germ cell tumor stage II extragonadal non-seminomatous germ cell tumor stage III extragonadal non-seminomatous germ cell tumor stage IV extragonadal non-seminomatous germ cell tumor adult teratoma testicular immature teratoma testicular mature teratoma stage IA ovarian germ cell tumor stage IB ovarian germ cell tumor stage IC ovarian germ cell tumor stage IIA ovarian germ cell tumor stage IIB ovarian germ cell tumor stage IIC ovarian germ cell tumor stage IIIA ovarian germ cell tumor stage IIIB ovarian germ cell tumor stage IIIC ovarian germ cell tumor
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-03-01; Completion date: 2016-06-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, 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. 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.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.

Detailed description:
OBJECTIVES:

* Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors.
* Determine the safety of this regimen in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.

After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Arms: arm 1: -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
Interventions: intervention 1: pegfilgrastim intervention 2: cisplatin intervention 3: ifosfamide intervention 4: paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: