Phase II Trial of Docetaxel in Patients With Metastatic or Inoperable Medullary Thyroid Cancer

Phase 1

• Conditions: Metastatic or inoperable medullary thyroid cancer

• Registration Number: EUCTR2006-005301-63-AT
• Lead Sponsor: niversity Hospital Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-22
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>To evaluate the activity of docetaxel (Taxotere®) on progression-free survival (PFS).<br>;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