AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT ID: NCT00574951

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31

Brief 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.

Detailed Description

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMG 706

AMG 706 daily

Group Type: EXPERIMENTAL

motesanib diphosphate

Intervention Type: DRUG

Interventions

motesanib diphosphate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell J. Schilder, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, United States

St. John's Regional Health Center

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Lake/University Ireland Cancer Center

Mentor, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Harrington Cancer Center

Amarillo, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

GOG-0170L

Identifier Type: -

Identifier Source: secondary_id

AMGEN-20060747

Identifier Type: -

Identifier Source: secondary_id

GOG-0170L

Identifier Type: -

Identifier Source: org_study_id