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

Phase 2

Terminated

Conditions: Primary Peritoneal Cavity Cancer
Ovarian Cancer
Fallopian Tube Cancer

Interventions: Drug: motesanib diphosphate

Registration Number: NCT00574951

Lead Sponsor: Gynecologic Oncology Group

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 706	motesanib diphosphate	AMG 706 daily

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) at 6 Months	CT scan or MRI every other cycle for the first 6 months	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study, time of progression could not be validly collected due to the study being prematurely closed secondary to severe neurological adverse events seen in 4 patients,
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	CT scan or MRI every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated up to 5 years.	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Secondary Outcome Measures

Name	Time	Method
Duration of Progression-free Survival (PFS)	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated, up to 5 years	Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study time of progression could not be validly collected due to the study being prematurely closed, secondary to severe neurological adverse events seen in 4 patients, and thus progression-free survival (PFS) cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE),
Duration of Overall Survival (OS)	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment	Number of participants with a maximum grade of 3 or higher during the treatment period.

Trial Locations

Locations (19): 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, New Jersey, United States
Hinsdale Hematology Oncology Associates
🇺🇸
Hinsdale, Illinois, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸
Burbank, California, United States
Lake/University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
Oklahoma University Cancer Institute
🇺🇸
Oklahoma City, Oklahoma, United States
St. Vincent Indianapolis Hospital
🇺🇸
Indianapolis, Indiana, United States
University of Virginia Cancer Center
🇺🇸
Charlottesville, Virginia, 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
Mount Carmel Health - West Hospital
🇺🇸
Columbus, Ohio, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Harrington Cancer Center
🇺🇸
Amarillo, Texas, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸
Reading, Pennsylvania, United States