AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: motesanib diphosphate
Intervention MeSH terms: Motesanib diphosphate; Imetelstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: fallopian tube cancer; recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

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.
    

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