Clinical trial NCT00574951: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: fallopian tube cancer
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-17
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
timeFrame: 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.
measure: Progression-free Survival (PFS) at 6 Months
timeFrame: CT scan or MRI every other cycle for the first 6 months
Secondary outcomes:
measure: Duration of Overall Survival (OS)
timeFrame: 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.
measure: Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
timeFrame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
measure: Duration of Progression-free Survival (PFS)
timeFrame: 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
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center - Burbank
state: California
city: New Britain
country: United States
facility: George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
state: Connecticut
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: Hinsdale Hematology Oncology Associates
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Indianapolis Hospital
state: Indiana
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper - Voorhees
state: New Jersey
city: Charlotte
country: United States
facility: Blumenthal Cancer Center at Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health - West Hospital
state: Ohio
city: Mentor
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Abington
country: United States
facility: Rosenfeld Cancer Center at Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Reading
country: United States
facility: McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
state: Pennsylvania
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
Study officials:
affiliation: Fox Chase Cancer Center
name: Russell J. Schilder, MD
role: STUDY_CHAIR
References: