TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma
Condition: Choriocarcinoma
MeSH terms: Choriocarcinoma
Intervention: TRC105; Bevacizumab
Intervention description: weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops; Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is
      effective in the treatment of two patients with metastatic and refractory choriocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willingness and ability to consent for self to participate in study

          2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
             tests, and other study procedures

          3. Measurable disease by RECIST 1.1 and elevated serum β-hCG

          4. Histologically proven choriocarcinoma that has progressed despite all described lines
             of chemotherapy for this condition

        Exclusion Criteria:

          1. Prior treatment with TRC105

          2. Serious dose-limiting toxicity related to prior bevacizumab

          3. Current treatment on another therapeutic clinical trial

          4. Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite
             optimal therapy (initiation or adjustment of BP medication prior to study entry is
             allowed provided that the average of 3 BP readings at a visit prior to enrollment is <
             140/90 mm Hg)

          5. Symptomatic pericardial or pleural effusions

          6. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2
             weeks

          7. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e.
             hereditary hemorrhagic telangiectasia)

          8. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days
             prior to first day of study therapy

          9. Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days

         10. Known active viral or nonviral hepatitis

         11. Open wounds or unhealed fractures within 28 days of starting study treatment

         12. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless
             treated for the condition and complete resolution has been documented by
             esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment

         13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
             related illness

         14. Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or may
             interfere with the interpretation of study results and, in the judgment of the
             Investigator, would make the patient inappropriate for this study