Condition category
Cancer
Date applied
18/08/2009
Date assigned
27/08/2009
Last edited
27/08/2009
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 Filip Geurs

ORCID ID

Contact details

Ziekenhuislaan 100
Halle
1500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGZHSM 005

Study information

Scientific title

The combination of metronomic taxanes and valproic acid and enoxaparin decreases tumour marker levels in taxane refractory tumour types: a single arm, single centre, non-randomised, phase II feasibility trial

Acronym

MTAX

Study hypothesis

Metronomic chemotherapy with taxanes creates an important anti-angiogenic effect. This anti-angiogenic effect is enhanced by histone deacetylase inhibitors like valproic acid. The intracellular accumulation of chemotherapy is facilitated by enoxaparin.

Ethics approval

Institutional Review Board of the Regionaal Ziekenhuis Sint Maria approved on the 7th April 2009

Study design

Single arm single centre non-randomised phase II feasibility trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the interventions section to request a patient information sheet

Condition

Advanced solid tumours, metastatic disease

Intervention

Patients will receive paclitaxel 20 mg/m^2/day on days 1 - 5 and 7 - 12 of a 21-day cycle. In patients with prior docetaxel exposure this becomes docetaxel 6 mg/m^2 on day 1 - 5 and 7 - 12 of a 21-day cycle. In both groups valproic acid 2 x 500 mg per day is added, and enoxaparin 40 mg is injected subcutaneously together with the chemotherapy.

Total duration of treatment: 6 months; follow-up duration: one year.

Intervention type

Drug

Phase

Phase II

Drug names

Paclitaxel, docetaxel, valproic acid, enoxaparin

Primary outcome measures

Tumour marker decrease (carcinoembryonic antigen [CEA], prostate specific antigen [PSA], cancer antigen 15-3 [CA 15-3]) as a marker of the anti-angiogenic potential, after week 1, and thereafter every three weeks.

Secondary outcome measures

Tumour response, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), measured at week 19.

Overall trial start date

10/04/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven metastatic solid tumours. Patients must have disease which has failed standard taxane based chemotherapy.
2. Greater than or equal to 18 years of age, either sex
3. Eastern Cooperative Oncology Group performance status (ECOG PS) less than or equal to 3
4. Life expectancy greater than or equal to 8 weeks
5. Evaluable (based on radiological assessments or tumour markers) disease
6. Recovered (i.e., to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0 Grade less than or equal to 1) from all toxicities associated with previous chemotherapy or radiotherapy (exception: patients may enter with continuing alopecia irrespective of CTCAE grade). The following intervals between starting last treatment must elapse:
6.1. Chemotherapy: at least 4 weeks
6.2. Mitomycin C or a nitrosourea: at least 6 weeks
6.3. Targeted therapy: at least 2 weeks or 2 half-lives, whichever is longer
6.4. Biologics: at least 4 weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Pregnant women, women who are lactating, or women of childbearing potential who are not currently on effective means of birth control
2. History of QT/QTc prolongation, clinically significant ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure New York Heart Association Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease
3. Active, ongoing infection, including viral hepatitis
4. Undergone major surgery within the last 4 weeks
5. Organ transplant recipients
6. New brain metastasis. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and baseline brain computed tomography (CT) with contrast or magnetic resonance imaging (MRI) within 2 weeks of initiation of study drug is negative for new brain metastases.
7. Patients who have been on other experimental clinical trials of investigational agents within the last 28 days

Recruitment start date

10/04/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Ziekenhuislaan 100
Halle
1500
Belgium

Sponsor information

Organisation

St Mary Hospital (Sint-Maria Ziekenhuis) (Belgium)

Sponsor details

c/o Mr Jan Claes
Directiesecretariaat
Ziekenhuislaan 100
Halle
1500
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.regzhsintmaria.be

Funders

Funder type

Industry

Funder name

GEURS FILIP BVBA (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes