Advanced solid tumours, metastatic disease Cancer Advanced solid tumours, metastatic disease
Conditions
Interventions
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
follow-up duration: one year.
Sponsors
St Mary Hospital (Sint-Maria Ziekenhuis) (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Tumour response, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), measured at week 19. | — |
Countries
Belgium
Outcome results
None listed