Metronomic chemotherapy with taxanes may reverse taxane resistance by anti-angiogenic effect
| ISRCTN | ISRCTN27587187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27587187 |
| Secondary identifying numbers | RGZHSM 005 |
- Submission date
- 18/08/2009
- Registration date
- 27/08/2009
- Last edited
- 27/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Filip Geurs
Scientific
Scientific
Ziekenhuislaan 100
Halle
1500
Belgium
Study information
| Study design | Single arm single centre non-randomised phase II feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the interventions section to request a patient information sheet |
| 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 |
| Study acronym | MTAX |
| Study objectives | 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(s) | Institutional Review Board of the Regionaal Ziekenhuis Sint Maria approved on the 7th April 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 10/04/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/04/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Ziekenhuislaan 100
Halle
1500
Belgium
1500
Belgium
Sponsor information
St Mary Hospital (Sint-Maria Ziekenhuis) (Belgium)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Jan Claes
Directiesecretariaat
Ziekenhuislaan 100
Halle
1500
Belgium
| Website | http://www.regzhsintmaria.be |
|---|
Funders
Funder type
Industry
GEURS FILIP BVBA (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
