Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Condition: Recurrent Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Carotuximab (TRC105)
Intervention description: Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with
      recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

          -  Measurable disease per RECIST 1.1

          -  At least one "target lesion" per RECIST 1.1

          -  Patients must have GOG Performance Status of 0 or 1

          -  Patients must have a life expectancy of ≥ 3 months

          -  Resolution of all acute toxic effects of prior therapy

          -  Free of active infection requiring antibiotics

          -  Must have had one prior platinum-based chemotherapeutic regimen for management of
             primary disease

          -  Patients could have received one additional cytotoxic regimen for management of
             recurrent disease

          -  Prior therapy directed at the malignant tumor, including hormonal and immunologic
             agents, must be discontinued at least three weeks prior to registration. Continuation
             of hormone replacement therapy is permitted.

          -  Adequate bone marrow function, renal function, hepatic function, neurologic function,
             blood coagulation parameters

          -  Negative serum pregnancy test and effective form of contraception for patients of
             childbearing potential

        Exclusion Criteria:

          -  Previous treatment with TRC105

          -  Current treatment on another therapeutic clinical trial

          -  Receipt of an investigational agent within 28 days of starting study treatment

          -  Serious, non-healing wounds, ulcers, or bone fractures.

          -  Active bleeding or pathologic conditions that carry a high risk of bleeding

          -  Patients with tumor involving major vessels or transmural bowel wall involvement by
             tumor

          -  Use of thrombolytic or anticoagulant agents (except heparin to maintain i.v.
             catheters) within 10 days prior to the first dose of TRC105

          -  History of deep venous thrombosis (DVT)(except patients who have received adequate
             anticoagulation are eligible, and may continue on anticoagulation if appropriate)

          -  History of peptic ulcer disease or erosive gastritis within the past 6 months

          -  Known active viral or nonviral hepatitis

          -  History or evidence of CNS disease

          -  Clinically significant cardiovascular disease

          -  Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human, chimeric, or humanized antibodies

          -  Pregnant or nursing

          -  Under the age of 18

          -  Patients with or with anticipation of invasive procedures including major surgical
             procedure, open biopsy or significant traumatic injury within 28 days prior to
             treatment with TRC105

          -  History of other invasive malignancies, except non-melanoma skin cancer and other
             cancers that have been treated with no evidence of disease within the last 3 years

          -  History of primary endometrial cancer diagnosed within the last 5 years, unless all of
             the following conditions are met: Stage not greater than I-B; no more than superficial
             myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated
             subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
             the last five years are excluded. Patients may have received prior adjuvant
             chemotherapy for localized breast cancer, provided that it was completed > 3 years
             prior to registration, and patient remains free of recurrent or metastatic disease

          -  Prior radiotherapy to any portion of the abdominal cavity or pelvis

          -  Patients with clinical symptoms or signs of gastrointestinal obstruction and who
             require parenteral hydration and/or nutrition