| Exclusion Criteria: | 1) Subjects with tumors confined to the thyroid.
2) Subjects with an uncontrolled, clinically significant active infection.
3) Clinically active brain metastasis, including symptomatic involvement, evidence of cerebral edema by prior CT or MRI, radiographic evidence of progression of brain metastasis since definitive therapy, or continued requirement for corticosteroids for cerebral edema.
4) Subjects who receive chemotherapy for metastatic ATC after completion of a combined modality approach
5) Subjects with history of malignancies other than ATC except: 1) preceeding lower grade thyroid malignancy; 2) curatively treated basal cell carcinoma of the skin; 3) curatively treated cervical intra-epithelial neoplasia; 4) curatively treated localized prostate cancer with a current PSA of < 4.0 mg/dL or ug/L. (Subjects with other curatively treated malignancies who have no evidence of metastatic disease will be considered after discussion with the Medical Monitor.)
6) Subjects with known intolerance of or hypersensitivity to CA4P or required premedications, or known uncontrolled hypersensitivity to paclitaxel, or carboplatin or CT contrast dye, or any of their components.
7) Subjects who are receiving concurrent investigational therapy or who have received investigational therapy for any indication within 28 days of the first scheduled day of dosing. (Investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication.)
8) Subjects with >/= Grade 3 peripheral neuropathy.
9) Subjects who are pregnant or lactating.
10) Subjects with a history of prior cerebrovascular event, including transient ischemic attack.
11) Subjects with uncontrolled hypertension defined as blood pressure > 140/90 mm Hg despite medication.
12) Subjects with symptomatic vascular disease (e.g., intermittent claudication)
13) Subjects with a history of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI) within the past 6 months, or NYHA Class III and IV congestive heart failure.
14) Subjects with a history of torsade de pointes, ventricular tachycardia, ventricular fibrillation or congenital long QT syndrome.
15) Subjects with bradycardia (<60 b/m) or heart block (excluding 1st degree block, consisting of PR interval prolongation only).
16) Subjects with ECG findings of clinically significant ventricular arrhythmia, new ST segment elevation or depression, or new Q wave on ECG. (PVCs are not excluded)
17) Subjects with QTc > 450 ms for males and >470 ms for females.
18) Subjects requiring on-going treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications
19) Subjects with ejection fractions less than normal (i.e. <45%).on echocardiogram.
20) Subjects with potassium concentrations below 4.0 mEq/L (or mmol/L), magnesium concentrations below 1.8 mmol/L. o Supplements may be used to increase electrolyte levels.
21) Subjects with a history of solid organ transplant or bone marrow transplant.
22) Subjects with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. |