Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Voreloxin Injection
Intervention description: All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: second line treatment; platinum resistant; ovary; ovaries; cancer; epithelial; carcinomas; tumor

Summary:

      The purpose of this study is to evaluate the objective response rate, safety and identify
      potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin
      injection given on a 28-day cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented epithelial ovarian cancer, primary
             peritoneal carcinoma, or fallopian tube cancer

          -  Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin,
             or another organoplatinum compound).

          -  Evidence of platinum-resistant disease, relapse/progression within 6 months of the
             completion of PBT, or intolerant to PBT (inability to receive PBT due to
             hypersensitivity reactions to platinum)

          -  Patients with primary platinum-resistant disease are allowed to receive no more than
             one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the
             management of recurrent or persistent disease after the development of primary
             platinum-resistance.

          -  Measurable disease per GOG-RECIST criteria

          -  GOG Performance Status of 0 or 1

        Exclusion Criteria:

          -  Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3
             weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of
             treatment.

          -  Monoclonal antibody therapy within 4 weeks prior to clinical study entry

          -  Unresolved or impending bowel obstruction

          -  Other active malignancies or other malignancies within the last 12 months except
             nonmelanoma skin cancer or cervical intraepithelial neoplasia

          -  Prior radiotherapy to more than 25% of the marrow space

          -  Requiring hemodialysis or peritoneal dialysis

          -  Myocardial infarction or cerebrovascular accident/transient ischemic attack within the
             6 months prior to the anticipated first day of treatment

          -  Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28
             days prior to the anticipated first day of treatment

          -  History of active CNS metastases

          -  Any other medical, psychological, or social condition that would contraindicate the
             patient's participation in the clinical study due to safety or compliance with
             clinical study procedures.

        Please note: There are additional inclusion/exclusion criteria for this study. Please
        contact the study center for additional information and to determine if you meet all study
        criteria.