Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Bendamustine HCL
Intervention description: bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
Intervention MeSH terms: Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; bendamustine

Summary:

      The study design is a non-randomized, open label, single center Phase II trial. Eligible
      patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary
      peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after
      primary treatment of their disease.

      Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1
      day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose
      will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
      20 patients will be enrolled in the study.

      OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine
      hydrochloride, in women with platinum and taxane refractory ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients must have histologically or pathologically confirmed diagnosis of epithelial
        carcinoma of the ovary, fallopian tube cancer or primary peritoneal serous papillary
        carcinoma. Borderline ovarian tumors are not allowed.

        2 Patients must have relapsed within 6 months of completing, or had a best response of
        increasing disease during any number of prior chemotherapy regimens with a platinum (either
        cisplatin or carboplatin) and a taxane (paclitaxel or docetaxel). These agents may have
        been administered concurrently or sequentially. Any number of additional regimens for
        recurrent disease will be allowed, as long as the patient performance status is 0-2
        Gynecologic Oncology Group (GOG).

        3 Patients must have measurable or evaluable (i.e. positive serum Cancer Antigen (CA) -125
        marker) disease. Scans or physical examinations used for tumor measurement must have been
        completed within 28 days prior to registration. Scans or ultrasounds for non -measurable
        disease must have been performed within 28 days prior to registration.

        4 Prior radiation is allowed as long as it encompassed no more than 25% of the bone marrow.
        Debulking surgery for relapsed disease is allowed as long as the patient has measurable or
        evaluable disease remaining after the surgery. Patient must have recovered from all side
        effects of surgery.

        5 Patients must not have received chemotherapy, biologic therapy or any other
        investigational drug for any reason within 28 days prior to registration. Patients must not
        have had a major surgery within 14 days prior to registration.

        6 Patients must have a GOG performance status of 0-2.

        7 Patients must have adequate liver function as defined by a serum bilirubin ≤2.0 x the
        institutional upper limit of normal (IULN), serum glutamic-oxaloacetic transaminase (SGOT)
        or serum glutamic-pyruvic transaminase (SGPT) ≤2.5 x the institutional upper limit of
        normal obtained within 14 days prior to registration.

        8 Patients must have an adequate renal function as defined by a serum creatinine ≤1.5x the
        institutional upper limit of normal obtained within 14 days prior to registration

        9 Patients must not have Class 3 /4 cardiac problems as defined by the New York Heart
        Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months
        of study)

        10 Patients must not be pregnant or nursing as bendamustine maybe harmful to the developing
        fetus and newborn. Women of reproductive potential must have a negative serum pregnancy
        test within 7 days prior to registration. Post-menopausal women must be amenorrheic for at
        least 12 months to be considered of non-childbearing potential. Patients of reproductive
        potential must agree to employ an effective barrier method of birth control throughout the
        study and for up to 3 months following discontinuation of study drug.

        11 No other prior malignancy is allowed except for the following: adequately treated basal
        cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or
        II cancer from which the patient is currently in complete remission, or any other cancer
        from which the patient has been disease-free for 5 years.

        12 Patients must have the following hematological criteria: Hemoglobin of ≥9gm/dL White
        blood cell count ≥ 2500 Platelets ≥ 100,000

        13 Patients must be ≥ 18 years of age.

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        Exclusion Criteria:

          1. No borderline ovarian tumors and mixed mesodermal soft tissue sarcomas

          2. No psychological, familial, sociological, or geographical conditions that do not
             permit medical follow-up or compliance with the study protocol

          3. Except for cancer-related abnormalities, patients should not have unstable or
             preexisting major medical conditions

          4. No medical life-threatening complications of their malignancies

          5. No known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled
             diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection,
             or HIV)

          6. Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 and/or
             diastolic blood pressure ≥100 mmHg on antihypertensive medications)

          7. New York Heart Association (NYHA) Grade III or greater congestive heart failure

          8. Evidence of 5 to ≤10% loss of weight from baseline (baseline defined as the screening
             weight taken approximately 14 days of Day 0) that is not related to ascites or
             paracentesis.

          9. Evidence of uncontrollable nausea

         10. Presence of central nervous system or brain metastases

         11. Known hypersensitivity to any component of bendamustine HCL

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