Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr TS Ganesan

ORCID ID

Contact details

Oxford Radcliffe Hospital
Oxford
0X3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00004876

Protocol/serial number

96.084

Study information

Scientific title

Acronym

Study hypothesis

Drugs used in chemotherapy use different ways to stop tumour cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumour.

This randomised phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ovarian cancer

Intervention

Patients entering the trial will be randomised to receive carboplatin (every 4 weeks for a maximum of six cycles) only or carboplatin with thalidomide (for 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last cycle of chemotherapy).

Intervention type

Drug

Phase

Not Specified

Drug names

Carboplatin, thalidomide

Primary outcome measures

1. Safety
2. Response
3. Markers of angiogenesis

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/1999

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed epithelial ovarian cancer
2. Post-menopausal or if pre-menopausal, patients must have had a bilateral salpingo-oophorectomy and/or a total abdominal hysterectomy
3. Stage Ic-IV ovarian cancer
4. Aged over 18 years
5. World Health Organisation (WHO) performance status 0, 1 or 2
6. Written informed consent
7. No previous carboplatin/cisplatin treatment for ovarian cancer
8. No other current invasive malignancy
9. Neither pregnant or with the ability to become pregnant
10. No chronic neurological disease causing peripheral neuropathy
11. No diabetes mellitus

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/1999

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Radcliffe Hospital
Oxford
0X3 9DU
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2011 results in www.ncbi.nlm.nih.gov/pubmed/21797111

Publication citations

  1. Results

    Muthuramalingam SR, Braybrooke JP, Blann AD, Madhusudan S, Wilner S, Jenkins A, Han C, Kaur K, Perren T, Ganesan TS, A prospective randomised phase II trial of thalidomide with carboplatin compared with carboplatin alone as a first-line therapy in women with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis., Eur. J. Gynaecol. Oncol., 2011, 32, 3, 253-258.

Additional files

Editorial Notes