Clinical trial NCT00466986 (phase 2, status: completed)
Conditions: ovarian cancer, fallopian tube cancer, primary peritoneal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C57.00, C57.01, C57.02, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: abraxane
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary
             peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO
             Classification.

          2. Measurable Disease by RECIST Criteria (defined by the presence of at least 1
             measurable lesion (see Section 7.7.1 for definition of measurable lesions) or elevated
             CA-125 in the absence of measurable disease. A pre-treatment sample of CA-125 will be
             collected within 2 weeks before treatment is started. A pre-treatment sample of CA-125
             should be at least twice the upper limit of normal.

          3. Patients must have disease recurrence 6 months or more after completion of front-line
             platinum and paclitaxel-containing regimen. Duration of response from prior therapy
             and prior consolidation therapy will be documented in case report forms for
             descriptive analysis.

          4. Patients must have received at least 3 cycles of a front-line taxane and
             platinum-containing regimen prior to entry on this study.

          5. Patients must have a documented complete clinical response on front-line therapy.

          6. Patients must be disease-free from prior malignancies for more than 5 years with the
             exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix.

          7. Life expectancy of > 6 months.

          8. ECOG (Zubrod) performance status 0-2.

          9. Age >18 years.

         10. Patient has the following blood counts at Baseline:

               -  ANC > 1.5 x 10-9 c/L;

               -  platelets > 100 x 10-9 c/L;

               -  Hgb > 9 g/dL.

         11. Patient has the following blood chemistry levels at Baseline:

               -  AST (SGOT), ALT (SGPT) < 1.5x upper limit of normal range (ULN);

               -  total bilirubin NORMAL;

               -  alkaline phosphatase < 2.5x ULN

               -  creatinine < 1.5 mg/dL.

         12. Patient or his/her legally authorized representative or guardian has been informed
             about the nature of the study, and has agreed to participate in the study, and signed
             the Informed Consent form prior to participation in any study-related activities.

        Exclusion Criteria:

          1. Patients who have received more than one prior chemotherapy regimen.

          2. Evidence of active brain metastases, including leptomeningeal involvement. Prior
             evidence of brain metastasis permitted only if treated and stable off therapy for at
             least 1 month.

          3. Patient has pre-existing peripheral neuropathy of grade >/= 2 (per National Cancer
             Institute [NCI] Common Terminology Criteria for Adverse Events version 3.0 [CTCAE].

          4. Patients receiving concurrent or intervening other chemotherapy, hormonal (for
             treatment of ovarian carcinoma), immunotherapy, or radiotherapy.

          5. Patient has a clinically significant concurrent illness.

          6. Patient is, in the Investigator's opinion, unlikely to be able to complete the study
             through the End of Study (EOS) visit.

          7. Patient has a history of allergy or hypersensitivity to the study drug.

          8. Patient has serious medical risk factors involving any of the major organ systems such
             that the investigator considers it unsafe for the patient to receive an experimental
             research drug.

          9. Patient is enrolled in any other clinical protocol or investigational trial.

         10. Patients of childbearing potential, not practicing adequate contraception.