Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Full description
OBJECTIVES:
OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents (yes vs no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
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:
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
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from all prior therapy (except alopecia) to NCI CTCAE v3.0 grade ≤ 1
No prior vandetanib
No prior docetaxel or any non-cytotoxic therapy (excluding hormonal therapy) for recurrent disease, regardless of whether it was part of primary treatment
At least 7 days since prior hormonal therapy for the malignant tumor
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
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
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
No other concurrent investigational or commercial agents
Primary purpose
Allocation
Interventional model
Masking
129 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal