S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced solid tumor, including, but not limited to the following:
• Non-small cell lung cancer
• Metastatic breast cancer
• Hormone-refractory prostate cancer
• Locally recurrent or metastatic head and neck cancer (including thyroid origin)
• Disease for which no standard therapy exists
• Tumor amenable to biopsy
• Measurable or non-measurable disease
• Brain metastases allowed provided patient has undergone brain irradiation (whole brain or gamma knife) AND the metastases have been clinically and radiologically stable for ≥ 6 weeks after completion of irradiation
• Patients requiring corticosteroids or anticonvulsants for brain metastases must be on a stable or decreasing dose of corticosteroids and seizure free for ≥ 28 days before study enrollment

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• PT/INR ≤ 1.1 times normal
• Serum creatinine ≤ 1.8 times ULN OR measured or estimated creatinine clearance > 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• Willing to undergo two tumor biopsies and blood and tissue sample submission for correlative laboratory studies
• No clinically significant cardiovascular event, including any of the following:
• Myocardial infarction or cerebrovascular accident within the past 3 months
• Unstable angina pectoris
• NYHA class II-IV heart disease within the past 3 months
• Symptomatic congestive heart failure
• Serious cardiac arrhythmia
• No history of cardiac disease that, in the investigator's opinion, increases the risk of ventricular arrhythmia
• No history of arrhythmia that is symptomatic or requires treatment (CTCAE grade 3), including any of the following:
• Multifocal premature ventricular contractions (PVCs)
• Bigeminy or trigeminy
• Ventricular tachycardia
• Uncontrolled atrial fibrillation
• Medically controlled atrial fibrillation allowed
• No asymptomatic sustained ventricular tachycardia
• No history of or evidence of any of the following on ECG:
• History of QTc prolongation as a result from other medication that required discontinuation of that medication
• Congenital long QT syndrome
• First degree relative with unexplained sudden death under 40 years of age
• Presence of left bundle branch block
• QTc with Bazett's correction that is unmeasurable or ≥ 480 msec on screening ECG
• No uncontrolled hypertension, defined as consistent systolic BP > 160 mm Hg or consistent diastolic BP > 100 mm Hg despite medical management
• No intractable nausea or vomiting
• No concurrent active diarrhea that may affect the ability to absorb or tolerate vandetanib
• No gastrointestinal (GI) tract disease resulting in malabsorption syndrome or a requirement for IV alimentation
• No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
• No history of allergic reactions attributed to docetaxel or compounds of similar chemical or biological composition to vandetanib, including other quinazoline compounds (e.g., gefitinib or erlotinib)
• No history of deep venous thrombosis or pulmonary embolism requiring therapeutic anticoagulation
• No known HIV positivity
• No other concurrent uncontrolled illness, including, but not limited to the following:
• Ongoing or serious active infection
• Psychiatric illness or social situation that would limit compliance with study requirements
• Prior or concurrent malignancies of other histologies within the past 5 years allowed

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior therapy (i.e., ≤ grade 2 alopecia and ≤ grade 1 toxicity from all other adverse events)
• Prior docetaxel as monotherapy or in combination with other chemotherapeutic agents allowed provided there is potential clinical benefit present, in the investigator's opinion, from the combination of docetaxel and vandetanib
• No prior vandetanib
• No prior surgical procedures affecting absorption
• More than 14 days since prior drugs with a short half-life (e.g., sorafenib or sunitinib) (approval by study coordinator required)
• More than 28 days since prior major surgery, chemotherapy, or radiotherapy
• More than 28 days since prior investigational agents
• More than 2 weeks since prior and no concurrent medications associated with a risk of causing Torsades de Pointes
• No concurrent therapeutic anticoagulation (coumadin, warfarin, or low-molecular weight heparin)
• Low-dose anticoagulation for indwelling catheter maintenance allowed
• No concurrent medication that may cause QTc prolongation
• No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for the treatment of cancer, except for the following:
• Luteinizing hormone-releasing hormone agonists
• Bisphosphonates