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| A placebo-controlled, double-blind, multicentre phase III trial to assess the efficacy and safety of miltefosine solution in the treatment of breast cancer where no other appropriate treatment is available |
| Source of record | UK Trials |
| ISRCTN | ISRCTN91258120 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | C121 |
| Public title | A placebo-controlled, double-blind, multicentre phase III trial to assess the efficacy and safety of miltefosine solution in the treatment of breast cancer where no other appropriate treatment is available |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Female, aged more than 18 years 2. Histologically or cytologically confirmed breast cancer with inoperable lesions, unsuitable for radiotherapy, inadequately manageable by radiotherapy or systemic endocrine or chemotherapy 3. Superficial nodular or "flat" skin lesions including (estimated depth 1 cm), at least one bidimensionally measurable and progressive lesion 4. Patients should have had at least one prior systemic endocrine or chemotherapy. Patients may take concomitant endocrine therapy only (endocrine therapy must have been unchanged for the last 12 weeks if ongoing at the time of study entry) 5. Performance status World Health Organisation (WHO) grade two with life expectancy of at least three months 6. Satisfactory haematological and blood chemistry values 7. Patients with no measurable lesions, skin lesions with estimated depth over 1 cm, ulcerated skin lesions over 10% of the area to be treated or local infection within the treated area are not eligible 8. No clinical evidence of brain metastases that would limit life expectancy to less than six months 9. Patients with progressive associated systemic metastases are not eligible 10. No previous malignancies within the last five years, except treated and cured carcinoma in situ of the cervix, non-melanoma skin cancer or cutaneous lymphepithelioma 11. No radiotherapy to skin lesions or chemotherapy within the last four weeks 12. No major surgery within the last two weeks 13. No uncontrolled clinically significant illness not related to cancer 14. The only permissible concomitant therapies are irradiation of non-skin lesions for symptom relief and endocrine therapy if it has remained unchanged for at least 12 weeks |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 30/04/1998 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to receive either: 1. Treatment A: Miltefosine, a 6% solution 2. Treatment B: Placebo solution The solution whether placebo or miltefosine is applied to the affected area initially once daily (two drops per 10 cm surface area, allowing for an approximately 3 cm margin around the visible lesion). Provided this has good tolerability the dose will be escalated to twice daily applications from week two onwards. In the absence of clear progression of skin lesions or dose-limiting adverse events a minimum treatment time of eight weeks is suggested. Patients who have a complete response should continue at the same dosage, if possible, for at least a further four weeks after the complete response is observed. Patients will be treated and/or followed-up until progression or occurrence of skin lesions within the treated area, treatment stop due to poor tolerability of the study medication, or necessity for a change in systemic therapy. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123 Lincoln's Inn Fields London United Kingdom WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91258120 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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