amg 706 in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: amg 706 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. purpose: this phase ii trial is studying how well amg 706 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

objectives: primary * to assess the activity of amg 706, in terms of the frequency of patients with progression-free survival for at least 6 months after initiating therapy or with an objective tumor response, in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma. secondary * to determine the frequency and severity of adverse events as assessed by ctcae v3.0. * to characterize the distribution of the progression-free and overall survival of these patients. outline: this is a multicenter study. patients receive oral amg 706 once daily on days 1-28. courses repeat every 28 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.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma * recurrent or persistent disease * measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral ct scan * must have at least one "target lesion" that can be used to assess response, as defined by recist criteria * tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistent disease ≥ 90 days following completion of radiotherapy * must have received one prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease * initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment * one additional cytotoxic regimen for management of recurrent or persistent disease allowed * patients must have a platinum-free interval of \< 12 months, have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy * ineligible for a higher priority gog protocol * no pleural effusion or ascites causing grade 2 or greater dyspnea * no history of uncontrolled cns metastases * patients with a history of cns metastases must have their disease controlled by radiotherapy and/or surgery; have at least two imaging scans following treatment (that were no less than 30 days apart) showing no progression of any lesions and no new lesions; and be clinically stable off corticosteroids for ≥ 14 days prior to study randomization patient characteristics: * gog performance status (ps) 0-2\* note: \*patients who have received 2 prior regimen must have a gog ps of 0-2 and patients who have received 2 prior regimens must have a gog ps of 0-1 * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * creatinine ≤ 1.5 times upper limit of normal (uln) * urine protein \< 30 mg/dl by urinalyses or ≤ 1+ by urine dipstick (unless quantitative protein is \< 500 mg by 24-hour urine collection) * bilirubin ≤ 1.5 times uln (\< 3 times uln in patients with ugt1a1 promoter polymorphism \[i.e., gilbert syndrome\] confirmed by genotyping or invader® ugt1a1 molecular assay) * ast and alt ≤ 2.5 times uln (5 times uln if liver metastases are present) * alkaline phosphatase ≤ 2 times uln (5 times uln if liver or bone metastases are present) * ptt normal * inr ≤ 1.5 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * able to swallow oral medications * cardiac ejection fraction normal * no sensory and motor neuropathy \> grade 2 * no other invasive malignancies within the past 5 years, except nonmelanoma skin cancer or other specific malignancies * no bleeding diathesis or hypercoagulopathy within the past 14 days * no arterial or venous thrombosis within the past 12 months * none of the following within the past 12 months: * myocardial infarction * cerebrovascular accident * transient ischemic attack * grade 2 or greater peripheral vascular disease * percutaneous transluminal coronary angioplasty/stent * congestive heart failure * ongoing arrhythmias requiring medication * unstable angina * no average systolic blood pressure ≥ 150 mm hg and average diastolic blood pressure ≥ 90 mm hg * patients with hypertension that is stable on a current dose of anti-hypertensives are eligible * no history of impaired cardiac status (e.g., severe heart disease, cardiomyopathy, or congestive heart failure) * no psychiatric, addictive, or other kind of disorder that would compromise the ability of the patient to give written informed consent * no open wounds, ulcers, or fractures * no active infection requiring antibiotics (with the exception of uncomplicated uti) * no known hiv, hepatitis b, or hepatitis c positivity * no known hypersensitivity to amg 706 prior concurrent therapy: * see disease characteristics * recovered form prior surgery, radiotherapy, or chemotherapy * at least 1 week since prior hormonal therapy for the malignant tumor * concurrent hormone replacement therapy allowed * at least 3 weeks since other prior therapy directed at the malignant tumor, including biologic or immunologic agents (i.e., small molecules or murine monoclonal antibodies) * at least 12 weeks since prior chimeric, human, or humanized monoclonal antibodies * more than 30 days since prior investigational therapy * more than 12 weeks since prior bevacizumab * more than 30 days since prior vegfr-targeted therapy, including, but not limited to, any of the following: * su5416 * su6668 * sunitinib malate * vandetanib * vatalanib * azd2171 * aee 788 * sorafenib * more than 28 days since prior major surgery * more than 14 days since prior minor surgery, including open breast biopsy * more than 7 days since prior core needle biopsy or placement of a central venous access device (including portion, tunneled, or non-tunneled catheters) * no prior cancer treatment that would contraindicate study therapy * no prior therapy amg 706 * no prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer * prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed \> 3 years ago, and the patient remains free of recurrent or metastatic disease * no prior non-cytotoxic chemotherapy for management of recurrent or persistent disease * no prior radiotherapy to any portion of the abdominal cavity or pelvis other than 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 \> 3 years ago, and the patient remains free of recurrent or metastatic disease * no concurrent coumadin-type anticoagulants, including warfarin, at doses \> 1 mg/day * concurrent low molecular weight heparin or low dose warfarin (i.e., ≤ 1 mg daily) for prophylaxis against central venous catheter thrombosis is allowed * no other concurrent investigational or antineoplastic agents

Keywords: fallopian tube cancer recurrent ovarian epithelial cancer primary peritoneal cavity cancer