Gem-TIP Trial | Southampton Clinical Trials Unit

Trial Name:

Gem-TIP - Phase I/II multicentre trial of salvage chemotherapy with Gem-TIP for relapsed germ cell cancer

Description:

Gem-TIP is a Phase II multi-centre trial of salvage chemotherapy with gemcitabine and TIP (Paclitaxel, Ifosfamide, Cisplatin) for relapsed germ cell cancer. This trial is for patients in first relapse following one previous cisplatin containing combination chemotherapy treatment for metastatic extracranial primary germ cell cancer.

Objectives:

To assess the maximally tolerated dose of Gem-TIP (+GCSF) when compared with TIP in the previous MRC study. The dose intensity of the drugs contained in TIP will be compared between the two studies with the aim of matching or exceeding the doses of TIP delivered. The dose of gemcitabine that can be delivered will then be assessed.
To measure response rates and failure free survival after Gem-TIP alone.
To assess the utility of PET scanning after Gem-TIP
chemotherapy.

Design:

Pre treatment investigations: Physical examination, full blood count, U&E, GFR, LFTs, AFP, HCG, LDH, Chest x-ray, CT head, chest, abdomen pelvis.

During chemotherapy: FBC twice weekly

Before each treatment cycle: WHO toxicity assessment, FBC, AFP, HCG, chest x-ray.

Post treatment assessment: CT of relevant sites, PET scan (optional), surgery as required

Status:

Completed

Population:

Patients in first relapse following one previous cisplatin containing combination chemotherapy treatment for metastatic extracranial primary germ cell cancer. Age range 16 – 60 years.

Publications:

Salvage chemotherapy with gemcitabine, paclitaxel, ifosfamide, and cisplatin for relapsed germ cell cancer

Contact details

All Trial enquiries should be addressed to ctu@soton.ac.uk