A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer
| ISRCTN | ISRCTN66284161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66284161 |
| Secondary identifying numbers | G37 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 15/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | 1. Arm A: Placebo tablet 2. Arm B: Nimopidine tablet |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nimopidine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1989 |
| Completion date | 01/01/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 01/01/1993 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW1 2DA
United Kingdom
Sponsor information
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/01/2019: The public and scientific titles have been changed from "A placebo-controlled trial of nimopidine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer" to "A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer". No publications definitively identified. All search options exhausted.
