Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
29/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Kelly Cozens

ORCID ID

Contact details

University of Southampton Clinical Trials Unit
MP 131
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

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 measures

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

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

http://www.suht.nhs.uk/home.aspx

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes