Trial Information

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

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.