E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic or inoperable medullary thyroid cancer |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Determine the safety and tolerability of Docetaxel (TAXOTERE®) in these patients. To evaluate the activity of docetaxel (Taxotere®) on progression-free survival (PFS).
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 1.5 mg/dL, ALT and AST < 2.5 times upper limit of normal, no unstable or uncompensated hepatic disease Renal: normale serum kreatinine values or creatinine clearance > 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |