Brief Title
AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Secondary Outcome
Duration of Overall Survival (OS)
Condition
Fallopian Tube Cancer
Intervention
motesanib diphosphate
Study Arms / Comparison Groups
AMG 706
Description: AMG 706 daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
December 2007
Primary Completion Date
July 2013
Eligibility 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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Russell J. Schilder, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00574951
Organization ID
GOG-0170L
Secondary IDs
GOG-0170L
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Russell J. Schilder, MD, Study Chair, Fox Chase Cancer Center
Verification Date
May 2015