Conditions: Primary Peritoneal Carcinoma Tumor Epithelial Ovarian Cancer Uterine Disease Cervix Diseases Neoplasms, Ovarian Cancer
Keywords: AGO Advanced, Gynaecologic cancer(s), Genetics GW786034, Pazopanib,
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

Detailed description:

Arms:
arm 1: Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles arm 2: Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles

Interventions: intervention 1: pazopanib (GW786034) intervention 2: carboplatin intervention 3: paclitaxel
Intervention descriptions: intervention 1: 800 mg orally once a day for 6 cycles intervention 2: IV over one hour every 3 weeks of 6 cycles intervention 3: IV 175 mg/m\^2 given over 3 hours on day one of a 21 day cycle for six cycles

Protocol document: