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

Gynecologic Oncology Group (GOG)

Status and phase

Terminated

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: motesanib diphosphate

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00574951

GOG-0170L

AMGEN-20060747

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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