Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00574951
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00574951
Study Brief:
Protocol Section:
NCT00574951