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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00574951 |
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 |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: motesanib diphosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 85 |
Study Start Date: | December 2007 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
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
Must have received one prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
No history of uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
None of the following within the past 12 months:
No average systolic blood pressure ≥ 150 mm Hg and average diastolic blood pressure ≥ 90 mm Hg
PRIOR CONCURRENT THERAPY:
At least 1 week since prior hormonal therapy for the malignant tumor
More than 30 days since prior VEGFR-targeted therapy, including, but not limited to, any of the following:
No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
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
No concurrent coumadin-type anticoagulants, including warfarin, at doses > 1 mg/day
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 | |
Hinsdale Hematology Oncology Associates | |
Hinsdale, Illinois, United States, 60521 | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
University of Illinois Cancer Center | |
Chicago, Illinois, United States, 60612-7243 | |
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 | |
Lake/University Ireland Cancer Center | |
Mentor, Ohio, United States, 44060 | |
Mount Carmel Health - West Hospital | |
Columbus, Ohio, United States, 43222 | |
United States, Oklahoma | |
Oklahoma University Cancer Institute | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
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 | |
Rosenfeld Cancer Center at Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001 | |
United States, Texas | |
Harrington Cancer Center | |
Amarillo, Texas, United States, 79106 | |
United States, Virginia | |
University of Virginia Cancer Center | |
Charlottesville, Virginia, United States, 22908 |
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000579062, GOG-0170L, AMGEN-20060747 |
Study First Received: | December 14, 2007 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00574951 History of Changes |
Health Authority: | United States: Food and Drug Administration |
fallopian tube cancer recurrent ovarian epithelial cancer peritoneal cavity cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |