Finding studies
Finding studies
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Lead
University of Southampton
With
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.
Age
16–60
Sex
ALL
Healthy volunteers
Not accepted
