| | Requirement |
| 1 | Histologically confirmed metastatic or unresectable solid
tumors for which standard curative or palliative measures
do not exist or are no longer effective or patient is intolerant of & for whom a taxane-based treatment is appropriate. |
| 2 | If patient diagnosed with advanced prostate ca, must have
progressed on or have been intolerant of a Docetaxel based regimen. |
| 3 | SWOG PS 0-2. |
| 4 | Life expectancy at least 3 mos. |
| 5 | 18 y/o and above. |
| 6 | No history of torsades de pointes ventricular arrhythmia. |
| 7 | QTc interval < 450 msec on bsl EKG. |
| 8 | If patient has QTc interval 450 msec or greater, on screening EKG, in the presence of normal serum Calcium & Mg, EKG may be repeated twice, at least 24 hrs apart. The average QTc from the 3 EKGs must be < 450 msec to be eligible.
Ineligible if has QTc with Bazett’s correction that is unmeasurable. |
| 9 | If receiving a drug that has risk of QTc prolongation, QTc must be < 460 msec. |
| 10 | If female, must not be pregnant or breastfeeding.
Women of reproductive potential must have negative pregnancy test within 7 days prior to treatment. Post-menopausal women must have been amenorrheic for 12 mos or more to be considered of non-childbearing potential. |
| 11 | Must agree to use contraception at study initiation & for
the duration of study participation. Sexually active males
must also use a reliable & appropriate method of
contraception. |
| 12 | Recovered from acute toxicities from previous surgery,
chemotherapy or radiotherapy. |
| 13 | ANC 1500 or greater; Platelets > 100,000; Hgb > 9.0. |
| 14 | Serum creat 1.5 mg/dl or less, or CrCL > 50 mL/min by
Cockcroft-Gault formula. |
| 15 | AST/ALT 2.5 (or less) x ULN [5.0 (or less) x ULN if with liver mets]. |
| 16 | Alkaline Phosphatase 2.5 (or less) x ULN [5.0 (or less) x ULN if with bone mets, & no evidence of liver mets, & bilirubin equal to or less than ULN); [5.0 (or less) x ULN if with liver mets]. |
| 17 | Serum bilirubin 1.5 or less. |
| 18 | If with peripheral neuropathy, must be Gr 1 or less. |
| 19 | Potassium 4.0 or greater; Serum calcium (ionized or adjusted for albumin) within normal; Magnesium within normal (all with or without supplementation). |
| 20 | No other concomitant treatment directed at the cancer. All prior therapy must have been completed 4 wks or more prior to enrollment. |
| 21 | Signed Informed Consent, including HIPAA authorization. |
| 1 | Colon or rectal cancer. |
| 2 | Evidence of severe or uncontrolled systemic disease or any concurrent condition which makes study participation undesirable or which would jeopardize study compliance. |
| 3 | Clinically significant cardiovascular event [e.g. heart attack, Superior Vena Cava Syndrome, NYHA heart disease Classification of 2 or greater] within 3 mos before entry, or cardiac disease that increases risk of ventricular arrhythmia. |
| 4 | History of arrhythmia (abnormal heart rhythm) which is symptomatic or requires therapy (Gr 3) or
asymptomatic sustained ventricular tachycardia. Atrial fibrillation, if controlled on medication, is not excluded. |
| 5 | QTc prolongation with other medications that required discontinuation of that medication. |
| 6 | Congenital long QT syndrome, or 1st degree relative with unexplained sudden death at < 40 y/o. |
| 7 | Presence of Left Bundle Branch Block. |
| 8 | Any concomittant medication that may cause QTc
prolongation or induce Torsades de Pointes.
Drugs that cannot be stopped are allowed; must be monitored closely. |
| 9 | Hypertension not controlled by medical therapy (Systolic BP >160 or Diastolic BP >100). |
| 10 | Currently active diarrhea that may affect ability to absorb Vandetanib or tolerate diarrhea. |
| 11 | Investigational agents within 30 days prior to study treatment. |
| 12 | Last dose of prior chemotherapy <4 wks before start of study treatment. |
| 13 | Last radiotherapy 4 wks or less before study treatment, except palliative radiation. |
| 14 | Unresolved toxicity from prior anti-cancer therapy > Gr 1. |
| 15 | Major surgery within 4 wks or incompletely healed surgical incision before study treatment. |
| 16 | Previous enrollment in current study. |
