Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C121
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Multicentre randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Miltefosine
Primary outcome measure
Added 06/08/09:
Time to treatment failure
Secondary outcome measures
Added 06/08/09
1. Rate of response
2. Cutaneous reactions
Overall trial start date
01/01/1998
Overall trial end date
30/04/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. 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
2. Clinical evidence of brain metastases that would limit life expectancy to less than six months
3. Patients with progressive associated systemic metastases
4. Previous malignancies within the last five years, except treated and cured carcinoma in situ of the cervix, non-melanoma skin cancer or cutaneous lymphepithelioma
5. Radiotherapy to skin lesions or chemotherapy within the last four weeks
6. Major surgery within the last two weeks
7. Uncontrolled clinically significant illness not related to cancer
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
Recruitment start date
01/01/1998
Recruitment end date
30/04/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
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 (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11689583
Publication citations
-
Results
Leonard R, Hardy J, van Tienhoven G, Houston S, Simmonds P, David M, Mansi J, Randomized, double-blind, placebo-controlled, multicenter trial of 6% miltefosine solution, a topical chemotherapy in cutaneous metastases from breast cancer., J. Clin. Oncol., 2001, 19, 21, 4150-4159.