NCT00470366

Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors
• Extragonadal Germ Cell Tumor
• Ovarian Cancer
• Teratoma
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	pegfilgrastim
DRUG	cisplatin
DRUG	ifosfamide
DRUG	paclitaxel

Timeline

• Start date: 2007-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2007-05-07
• Last updated: 2017-11-28
• Results posted: 2017-10-24

Locations

2 sites across 1 country: United States