Metastatic or inoperable medullary thyroid cancer
Conditions
Interventions
Trade Name: Taxotere concentrate and solvent for solution for infusion
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University Hospital Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent Histologically confirmed medullary thyroid cancer Meatastatic or inoperable locoregional disease Disease assesable by CT scan Age 18 - 75 ECOG Performance status 0-2 Life expectancy more than 3 months Hematopoietic: Leukocyte count > 3,000/mm^3, Platelet count > 100,000/mm^3 Hepatic: Bilirubin 60 mL/min, no unstable or uncompensated renal disease Cardiovascular : no unstable or uncompensated cardiovascular disease Pulmonary: no unstable or uncompensated respiratory disease In women of childbearing age: negative pregnancy test and sufficient method of contraception during the whole duration of therapy No other severe or uncontrolled systemic disease No other illness that would preclude study participation No other significant clinical disorder or laboratory finding that would preclude study participation More than 4 weeks since prior biologic therapy More than 4 weeks since prior chemotherapy or complete reconstitution of blood counts (i.e. Leuko > 3000, Thrombo > 100.000) No prior radiotherapy to > 25% of bone marrow More than 4 weeks since prior radiotherapy or complete reconstitution of blood counts (i.e. Leuko > 3000, Thrombo > 100.000) Surgery Full recovery from prior oncologic or other major surgery, minimal time span of 3 weeks following surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Absence of inclusion criteria (as stated above) Use of any investigational agent in the month prior to inclusion History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years Major surgery, other than diagnostic surgery, within the last 3 weeks Evidence of CNS involvement A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs Significant polyneuropathy interfering with everyday activities Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) <1.0 x 109/L Renal insufficiency Patients with active opportunistic infections Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the capacity of Docetaxel (TAXOTERE®) to induce objective responses in patients with metastatic or locally inoperable medullary thyroid cancer or at relapse after surgery or immunotherapy.;Secondary Objective: Determine the safety and tolerability of Docetaxel (TAXOTERE®) in these patients. To evaluate the activity of docetaxel (Taxotere®) on progression-free survival (PFS). ;Primary end point(s): The primary endpoint of this study is to evaluate the capacity of Docetaxel (TAXOTERE®) to induce objective responses in patients with metastatic or locally inoperable medullary thyroid cancer or at relapse after surgery or immunotherapy | — |
Countries
Austria
Outcome results
None listed