NCT00551122

Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors

Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.

Detailed description

OBJECTIVES: * To determine the maximum tolerated dose (MTD) of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (Gem-TIP) in patients with progressive or relapsed metastatic germ cell tumors. * To compare the MTD of the Gem-TIP regimen with the MTD determined in a previous Medical Research Council study of TIP alone. * To compare the degree of dose intensification achieved with Gem-TIP chemotherapy with that achieved in the prior study of TIP chemotherapy alone. * To assess the dose of gemcitabine hydrochloride that can be delivered with the TIP regimen in these patients. * To measure response rates and failure-free survival of patients treated with Gem-TIP alone. * To assess the utility of PET scanning after Gem-TIP chemotherapy in these patients. OUTLINE: This is a multicenter, phase I dose-escalation study of gemcitabine hydrochloride followed by a phase II study. * Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes and paclitaxel IV over 3 hours on day 1, cisplatin IV over 4 hours on days 1-5, and ifosfamide IV over 1 hour on days 2-6. Patients also receive filgrastim or lenograstim (G-CSF) subcutaneously (SC) on days 7-18 or until blood counts recover OR pegfilgrastim SC once on day 6. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Phase II: An additional cohort of 14 patients is treated as in phase I at the MTD determined in phase I. After completion of study therapy, patients are followed periodically for up to 1 year and then at the investigator's discretion.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
BIOLOGICAL	lenograstim
BIOLOGICAL	pegfilgrastim
DRUG	cisplatin
DRUG	gemcitabine hydrochloride
DRUG	ifosfamide
DRUG	paclitaxel

Timeline

• Start date: 2006-11-01
• Primary completion: 2013-04-01
• First posted: 2007-10-30
• Last updated: 2013-01-23

Locations

3 sites across 1 country: United Kingdom