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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00574951
First received: December 14, 2007
Last updated: April 19, 2011
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: motesanib diphosphate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of AMG 706 (IND # 79,697) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]
  • Progression-free survival (PFS) at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of adverse effects as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Duration of PFS and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574951

Locations
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Rush University Medical Center
Chicago, Illinois, United States, 60612
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Missouri
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00574951     History of Changes
Other Study ID Numbers: CDR0000579062, GOG-0170L, AMGEN-20060747
Study First Received: December 14, 2007
Last Updated: April 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
fallopian tube cancer
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014