Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

Phase 2

Completed

• Conditions: Tumor; Epithelial Ovarian Cancer; Cervix Diseases; Primary Peritoneal Carcinoma; Cancer; Uterine Disease; Neoplasms, Ovarian
• Interventions: Drug: pazopanib (GW786034); Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT00561795
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2009-07-22
• Disposition First Submitted QC: 2009-07-22
• Disposition First Posted: 2009-08-10
• Results First Submitted: 2009-11-19
• Results First Submitted QC: 2010-12-03
• Results First Posted: 2010-12-07
• Status Verified: 2011-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	pazopanib (GW786034)	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 A	paclitaxel	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 B	pazopanib (GW786034)	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
Arm B	paclitaxel	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
Arm B	carboplatin	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
Arm A	carboplatin	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events	Baseline to End of Study (up to a year)	Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the "Adverse Event" section of the results record for additional details and data.

Secondary Outcome Measures

Name	Time	Method
Overall Response	Baseline until either response or progression (up to 2 years)	Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Cancer Antigen (CA-125) Response	Baseline until response (up to 2 years)	Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.
18-week Progression Free Survival	Baseline to Week 18	Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Essen, Nordrhein-westfalen, Germany