Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Docetaxel; Carboplatin
Intervention description: For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin
For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin; Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.
Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed ovarian cancer

Summary:

      The purpose of this study is to compare the progression-free survival of two treatment
      regimens for relapsed ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal
             carcinoma.

          -  The patient's tumor is platinum-sensitive, which means that the patient had a complete
             response to front-line treatment with a platinum compound and had a treatment-free
             interval without clinical evidence of progressive disease for greater than 6 months.

          -  The patient has received one and only one prior chemotherapy regimen for the treatment
             of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is
             allowed. Patients who have received consolidation treatment are allowed. Prior
             treatment with Taxotere® is not allowed.

             o Consolidation therapy is allowed including a different cytotoxic agent than the
             agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and
             immunotherapy.

          -  Patients may have received one prior regimen with a biologic therapy, either combined
             with cytotoxic therapy in the front-line setting, or as a single-agent for this
             recurrence. The biologic therapy must be discontinued at least three weeks prior to
             registration.

          -  Measurable or evaluable disease either by radiologic imaging, or physical exam, or by
             measurement of CA125 < 70 on two occasions at least one week apart.

          -  At least 3 weeks since radiotherapy, with full recovery. The measurable disease must
             be completely outside the radiation portal.

          -  At least 3 weeks since major surgery, with full recovery. Patients who have undergone
             a secondary tumor debulking or cytoreductive surgery for this malignancy are excluded.

          -  Eastern Cooperative Oncology Group (ECOG) performance status < 2.

          -  Age > 18 years.

          -  Absolute neutrophil count > 1,500/mm3; platelet count > 100,000/mm3; Hemoglobin > 8.0
             g/dl

          -  Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must
             be within the range allowing for eligibility.

          -  If there is childbearing potential, a serum pregnancy test must be negative.

          -  Patients of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for three months following the completion of
             treatment.

          -  Informed consent has been obtained.

        Exclusion Criteria:

          -  Prior treatment with Taxotere®.

          -  Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for
             the disease. Any hormonal therapy directed at the malignant tumor must be discontinued
             at least one week prior to enrollment in order for the patient to be eligible to
             participate in this trial. Continuation of Hormone Replacement therapy is permitted.

          -  Serious concurrent medical or psychiatric illness, including serious active infection.

          -  Peripheral neuropathy > grade 2.

          -  History of other malignancy within the last 5 years, except for basal cell skin
             carcinoma.

          -  The patient is pregnant or nursing.

          -  Patients with a history of severe hypersensitivity reaction to cisplatin, carboplatin,
             mannitol, or drugs formulated with Polysorbate 80.

          -  Secondary debulking for this recurrence.