Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms
Keywords: Ovarian Cancer Primary Fallopian Tube Cancer Peritoneal Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

Detailed description:
MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent

1. to treat a CA125-only relapse, or
2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
3. to prolong a second response to chemotherapy.

Arms:
arm 1: Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2). arm 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Interventions: intervention 1: Farletuzumab intervention 2: Chemo Plus Far
Intervention descriptions: intervention 1: Weekly Farletuzumab infusions Dose dependent on dosing group intervention 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Protocol document: