Study of Ramucirumab in Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Ramucirumab
Intervention description: Participants will receive ramucirumab at 8 milligrams/kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
Intervention MeSH terms: Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer,; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary:

      The purpose of this study is to determine if ramucirumab given as monotherapy is effective in
      the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary
      Peritoneal Carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant must meet the following criteria to be enrolled in this study:

          1. The participant has recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma. Histologic documentation of the original primary tumor
             is required via a pathology report

          2. The participant has at least one unidimensional-measurable target lesion [≥ 2
             centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography
             (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST). Tumors within a previously irradiated field will be
             designated as "nontarget" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

          3. The participant has recovered to Grade ≤ 1 by the National Cancer Institute Common
             Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects
             of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted
             therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy
             (which must have resolved to Grade ≤ 2). Any other prior therapy directed at the
             malignant tumor must be discontinued at least three weeks prior to the first dose of
             study medication, or hormonal therapy discontinued at least one week prior to the
             first dose of study medication. Continuation of hormone replacement therapy is
             permitted

          4. The participant has completed at least one platinum-based chemotherapeutic regimen for
             management of primary disease, and must have at least one of the following: a
             platinum-free interval of < 12 months after the final dose of primary platinum-based
             therapy, progression during platinum-based therapy, or persistent disease after
             platinum-based therapy

          5. The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS)
             of 0-1 at study entry

          6. The participant has adequate hematological functions [absolute neutrophil count (ANC)
             ≥ 1200 cells/microliter (uL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥
             100,000 cells/uL]

          7. The participant has adequate hepatic function [bilirubin ≤ 1.5 times the upper limit
             of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 3.0
             times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver
             metastases]

          8. The participant has adequate renal function [serum creatinine ≤ 1.5 x ULN or
             creatinine clearance (measured or calculated) ≥ 60 milliliters/minute (mL/min)]

          9. The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If
             urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine
             must be collected and must demonstrate < 1000 milligrams (mg) of protein in 24 hours
             to allow participation in the study

         10. The participant has adequate coagulation function, as defined by international
             normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if
             not receiving anticoagulation therapy. Participants on full-dose anticoagulation must
             be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on
             warfarin must have therapeutic INR and have no active bleeding (defined as within 14
             days of first dose of study medication) or pathological condition that carries a high
             risk of bleeding (example, tumor involving major vessels or known varices)

         11. For participants who have received anthracycline therapy, the left ventricular
             ejection fraction (LVEF) must be within normal institutional range by a pretreatment
             echocardiogram or multigated acquisition (MUGA) scan

         12. If sexually active, the participant is post-menopausal, surgically sterile, or using
             effective contraception in the opinion of the investigator

         13. The participant is ≥ 18 years of age

         14. The participant has a life expectancy of ≥ 3 months

         15. The participant is able to provide informed written consent and is amenable to
             compliance with protocol schedules and testing

        Exclusion Criteria:

          1. The participant has a concurrent active malignancy, other than adequately treated
             nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A
             participant with previous history of malignancy is eligible provided that she has been
             disease-free for > 3 years

          2. The participant has received a noncytotoxic regimen (usually called targeted therapy
             such as bevacizumab) for recurrent or persistent disease. (Participants may have
             received a noncytotoxic regimen as primary treatment.)

          3. The participant has received radiotherapy for the treatment of ovarian, fallopian
             tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of
             study medication

          4. The participant has received prior radiotherapy to any portion of the abdominal cavity
             or pelvis other than for the treatment of ovarian, fallopian tube, or primary
             peritoneal cancer within the last 3 years. [Prior radiation for localized cancer (for
             example, of the breast, head and neck, or skin) is permitted, provided that it was
             completed > 3 years prior to the first dose of study medication, and the participant
             remains free of recurrent or metastatic disease.]

          5. The participant has received prior chemotherapy for any abdominal or pelvic tumor,
             other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer
             < 3 years prior to the first dose of study medication. Prior adjuvant chemotherapy for
             localized breast cancer is permitted, provided that it was completed >3 years prior to
             the first dose of study medication, and that the participant remains free of recurrent
             or metastatic disease

          6. The participant has undergone major abdominal surgery within 4 weeks (28 days) prior
             to first dose of study medication

          7. The participant has a suspected impending bowel obstruction, based on clinical or
             radiographic criteria

          8. The participant has received any hormonal therapy directed at the malignant tumor
             discontinued therapy within 1 week (7 days) prior to first dose of study medication

          9. The participant has received any other prior therapy directed at the malignant tumor,
             including immunologic agents, within 3 weeks (21 days) prior to first dose of study
             medication

         10. The participant has received previous treatment with ramucirumab

         11. The participant has participated in clinical trials of experimental agents within 4
             weeks (28 days) prior to first dose of study medication

         12. The participant has a history of uncontrolled hereditary or acquired bleeding or
             thrombotic disorders

         13. The participant has an ongoing or active infection requiring systemic antibiotics,
             symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly
             controlled cardiac arrhythmia, myocardial infarction < 6 months, Grade ≥ 2 peripheral
             vascular disease, poorly controlled hypertension despite standard medical management
             poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social
             situations that would limit compliance with study requirements, or any other serious
             uncontrolled medical disorders in the opinion of the investigator

         14. The participant has any history of brain metastases or leptomeningeal disease.
             Screening for central nervous system (CNS) involvement for testing asymptomatic
             participants is not required

         15. The participant has known human immunodeficiency virus infection or acquired
             immunodeficiency syndrome-related illness

         16. The participant is pregnant [confirmed by serum beta human chorionic gonadotropin
             (β-HCG) test] or lactating