S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

OBJECTIVES:

• To evaluate the clinical efficacy of docetaxel and vandetanib relative to docetaxel alone in patients with platinum-resistant, recurrent, refractory, or progressive/persistent ovarian epithelial, primary peritoneal, or fallopian tube cancer, as measured by progression-free survival.
• To evaluate the response rate (complete and partial) and duration of overall survival of these patients.
• To evaluate the response (complete and partial) and time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel.
• To evaluate the frequency and severity of adverse events as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.
• To evaluate the toxicity of single agent vandetanib following docetaxel as assessed by CTCAE v4.0.

OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
• Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

• Recurrent, refractory, or progressive/persistent disease
• Measurable or non-measurable disease documented by CT scan of the abdomen and pelvis
• Must have received 1 prior platinum-based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or other organoplatinum compound

• Initial treatment may have included any of the following:

• High-dose therapy
• Consolidation therapy
• Non-cytotoxic agent therapy
• Extended therapy administered after surgical or non-surgical assessment
• Additional cytotoxic regimen for recurrent, refractory, or progressive/persistent disease, including re-treatment with primary treatment regimen
• No more than 3 prior regimens for recurrent, refractory, persistent, or progressive disease.

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• Absolute neutrophil count (ANC) ≥ 1,500/mcl
• Platelet count ≥ 100,000/mcl
• Serum creatinine normal OR calculated creatinine clearance ≥ 30 mL/min
• Urine protein:creatinine ratio < 1
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• aspartate aminotransferase - alanine aminotransferase (AST or ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of vandetanib therapy
• No neuropathy ≥ grade 2 CTCAE v4.0
• No active infection requiring systemic or intravenous antibiotics
• No significant traumatic injury within the past 28 days
• No significant cardiovascular disease, including any of the following:

• Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 140 mm Hg or diastolic BP > 90 mm Hg) within the past 28 days
• Myocardial infarction superior vena cava syndrome, or New York Heart Association (NYHA) class II-IV heart disease within the past 3 months
• Presence of left bundle branch block
• Congenital long QT syndrome or first degree relative with unexplained sudden death < 40 years of age
• QT interval with Bazett's correction that is unmeasurable or ≥ 480 msec by screening ECG
• History of symptomatic arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) requiring treatment (≥ CTCAE grade 3) or asymptomatic sustained ventricular tachycardia

• Atrial fibrillation controlled on medication allowed

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy (except alopecia) to NCI CTCAE v3.0 grade ≤ 1
• No prior vandetanib

• Treatment with other anti-vascular endothelial growth factor (VEGF) targeted therapy allowed
• No prior docetaxel or any non-cytotoxic therapy (excluding hormonal therapy) for recurrent disease, regardless of whether it was part of primary treatment

• Prior docetaxel as part of front-line cytotoxic regimen (including maintenance therapy) allowed as long as no disease progression on or within 6 months after receiving docetaxel
• At least 7 days since prior hormonal therapy for the malignant tumor

• Concurrent hormone replacement therapy for menopausal symptoms allowed
• At least 28 days since other prior therapy for the malignant tumor, including immunologic agents
• More than 7 days since prior minor surgical procedures, fine needle aspirates, or core biopsies
• More than 14 days since prior and no concurrent potent inducers of cytochrome P450 3A4 (CYP3A4) function
• More than 14 days since prior and no concurrent medications having a risk of causing Torsades de Pointes or risk of QTc prolongation

• Patients receiving a drug that has a risk of QTc prolongation must not have QTc ≥ 460 msec
• More than 28 days since prior investigational agents for any purpose
• More than 28 days since prior and no concurrent major surgical procedure or open biopsy
• More than 5 years since prior chemotherapy for abdominal or pelvic tumor, except treatment of ovarian, fallopian tube, or primary peritoneal cancer

• Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease
• More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

• Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease
• No prior radiation to more than 25% of marrow-bearing areas

• More than 28 days since prior radiotherapy
• No other concurrent investigational or commercial agents