Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G37
Study information
Scientific title
A placebo-controlled trial of nimopidine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Placebo-controlled trial
Primary study design
Interventional
Secondary study design
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
Ovarian cancer
Intervention
1. Arm A: Placebo tablet
2. Arm B: Nimopidine tablet
Intervention type
Drug
Phase
Not Applicable
Drug names
Nimopidine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1989
Overall trial end date
01/01/1993
Reason abandoned
Eligibility
Participant inclusion criteria
1. Confirmed diagnosis of invasive epithelial ovarian cancer
2. International Federation of Gynaecology and Obstetrics (FIGO) stages Tc - Tv
3. 18-70 years old
4. Performance Status less than or equal to 2
5. White Blood Cells at least 4 x 10^9/l
6. Platelets at least 120 x 10^9/l
7. Creatinine or Ethylene Diamine Tetraacetic Acid (EDTA) clearance greater than or equal to 60 ml/min
8. Normal Bilirubin
9. Serum glutamic-oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) less than or equal to twice normal limit
10. No previous chemotherapy or radiotherapy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1989
Recruitment end date
01/01/1993
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
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
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
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