SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin
Condition: Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Intervention: SJG-136; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well SJG-126 works in treating patients with epithelial
      ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous
      treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have persistent or recurrent epithelial ovarian, primary peritoneal, or fallopian
             tube carcinoma, with histologic confirmation of the original primary tumor.

          -  Must have had at least one prior platinum-based (cisplatin or carboplatin)
             chemotherapy regimen for the management of their primary disease. This would include
             intraperitoneal chemotherapy.

          -  Must be considered platinum refractory or resistant, defined as patients with
             progression of disease during platinum-based chemotherapy, patients having persistent
             disease at the completion of platinum-based chemotherapy, or patients having a disease
             free interval following prior platinum therapy of less than six months.

          -  May have had no more than three prior treatment regimens for their epithelial ovarian,
             primary peritoneal or fallopian tube carcinoma. Consolidation or maintenance therapy
             initiated within six weeks of the completion of primary therapy will not be counted as
             an additional regimen.

          -  Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
             1.1 criteria.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

          -  Time interval from last chemotherapy, radiotherapy, or surgery of at least four weeks
             and the patient must have recovered from any significant adverse effects of prior
             treatment. Patients must be at least six weeks from having received nitrosoureas or
             mitomycin C.

          -  Life expectancy greater than three months.

          -  Must have adequate bone marrow and organ function:

               -  Leukocyte count > 3 x 10^9/L

               -  Absolute neutrophil count (ANC) > 1.5 x 10^9/L

               -  Platelet count > 100 x 10^9/L

               -  Total bilirubin Within normal institutional limits

               -  Aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 x institutional
                  upper limits of normal

               -  Creatinine < 1.5 mg/dL or calculated creatinine clearance (ClCr) > 60 ml/min by
                  Cockcroft Gault method, as below. ClCr = weight (kg) x (140-age) x 0.85 72 x
                  serum creatinine (mg/dL)

          -  Participants must have signed an approved informed consent.

          -  Participants of childbearing potential must have a negative serum pregnancy test prior
             to study entry and must use an effective form of contraception.

          -  Must have archival tissue available from their original tumor debulking surgery for
             assessment of BRCA1 protein expression.

        Exclusion Criteria:

          -  Patients with borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord
             stromal tumors, or other non-epithelial ovarian tumors are not eligible.

          -  Patients receiving any other investigational agents.

          -  Patients who have received radiation therapy to more than 25% of the bone marrow.

          -  Patients who have previously received SJG-136 or related compounds.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing active
             infection, symptomatic congestive heart failure, unstable angina pectoris,
             uncontrolled cardiac arrhythmias, or psychiatric illness/social situations that would
             limit compliance with the study requirements.

          -  Prior malignancy (other than cervical carcinoma in situ, ductal carcinoma in situ of
             the breast, or non-melanoma skin cancer) unless treated with curative intent and
             without evidence of disease for three years.

          -  With the exception of alopecia (or other situations in which the organ dysfunction or
             symptoms are considered clinically insignificant or irrelevant to the study), patients
             may not have baseline organ dysfunction or symptoms that qualify as grade 2 or higher
             by the CTEP Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. Particular
             attention should be paid to assessment of pre-existing edema, since vascular leak
             syndrome was the dose limiting toxicity of this agent in the phase I trial.