Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
04/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

http://www.cancer.org.uk

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

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11689583

Publication citations

  1. 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.

Additional files

Editorial Notes