Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer
- 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
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I)
end of study
G. Mead, MD
University Hospital Southampton NHS Foundation Trust.
United Kingdom: Medicines and Healthcare Products Regulatory Agency