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 |
| Protocol serial number | G37 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nimopidine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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.
