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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list