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

NCT00574951 | Terminated Phase 2 Results DMC

• 2 other identifiers: GOG-0170LAMGEN-20060747
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 19

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

fallopian tube cancer; recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

  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.

  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.

• Progression-free Survival (PFS) at 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,

  CT scan or MRI every other cycle for the first 6 months

Secondary Outcomes (3)

• 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.

• 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

• 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

Study Arms (1)

AMG 706

EXPERIMENTAL

AMG 706 daily

Drug: motesanib diphosphate

Interventions

motesanib diphosphate DRUG

AMG 706

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

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

New Britain, Connecticut, 06050, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

motesanib diphosphate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Angela Kuras on behalf of Mike Sill, PhD
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• Russell J. Schilder, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2013
• Last Updated: January 11, 2018
• Results First Posted: January 11, 2018

Record last verified: 2015-05

Locations

US (19)