Plain English Summary
Trial website
Additional identifiers
EudraCT number
2004-004804-19
ClinicalTrials.gov number
NCT00551122
Protocol/serial number
1447
Study information
Scientific title
A non-randomised multicentre phase I/II interventional trial of a tolerable salvage chemotherapy regimen for patients with metastatic germ cell cancer who have failed first-line chemotherapy
Acronym
Gem-TIP
Study hypothesis
The purpose of this study is to develop a tolerable, highly active, salvage chemotherapy regimen to be used in patients with metastatic germ cell cancer who have failed first-line chemotherapy.
On 01/03/2011 the target number of participants was changed from 28 to 14.
Ethics approval
Southampton and South west Hampshire REC A, 05/04/2005, ref: 05/Q1702/22
Study design
Non-randomised multicentre interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Testis Cancer; Disease: Testis
Intervention
4 cycles of chemotherapy, 4 cycles of chemotherapy using gemcitabine and paclitaxel, ifosfamide, cisplatin (TIP) regimen.
Follow Up Length: 12 month(s)
Study Entry : Registration only
Intervention type
Drug
Phase
Phase II
Drug names
Gemcitabine, paclitaxel, ifosfamide, cisplatin
Primary outcome measure
To assess the maximally tolerated dose of Gem-TIP (+Granulocyte colony-stimulating factor [+GCSF]) when compared with TIP, established in the phase 1 aspect of the trial
Secondary outcome measures
To measure response rates and failure free survival after Gem-TIP alone, assessed at 1, 2, 3, 4, 6, 8 10 and 12 months post-treatment
Overall trial start date
11/10/2005
Overall trial end date
04/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First relapse after single previous cisplatin-containing combination chemotherapy for metastatic extracranial primary germ cell cancer, seminoma and non-seminoma, male or female patients
2. All cases must have either rising serum markers (alphafetoprotein [AFP], human chorionic gonadotropin [HCG]) on sequential measurement, or biopsy-proven unresectable germ cell cancer. Patients with completely resected cancer are not eligible for this study. Patients with late relapse (greater than 2 years post-initial chemotherapy) should be considered for surgery rather than chemotherapy where technically feasible. Patients with cerebral metastases alone are not eligible. Patients with progressive cerebral and systemic disease may be considered for this study. However, it is recommended that cranial irradiation also be considered a component of care.
3. Aged 16 - 60 years
4. Considered medically and psychologically fit to receive this intensive chemotherapy schedule
5. White blood cells (WBC) greater than 3.5 x 10^9/l. Platelets greater than 130 x 10^9/l
6. Glomerular filtration rate (24 hours)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
14 (28 at time of registration)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
11/10/2005
Recruitment end date
04/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton Clinical Trials Unit, MP 131
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list