Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

Study Overview

To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer.

To determine the response rate by RECIST criteria. To determine the progression free survival. To determine the median survival and overall survival at one year.

Pancreatic Cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-03-02	Results First Submitted 2015-05-04	Last Update Submitted that met QC Criteria 2015-05-22
First Submitted that Met QC Criteria 2010-03-03	Results First Submitted that Met QC Criteria 2015-05-22	Last Update Posted (ESTIMATED) 2015-06-09
First Posted (ESTIMATED) 2010-03-04	Results First Posted 2015-06-09	Last Verified 2015-05

Study Registration Dates

Results Reporting Dates

Study Record Updates

First Submitted

2010-03-02

Results First Submitted

2015-05-04

Last Update Submitted that met QC Criteria

2015-05-22

First Submitted that Met QC Criteria

2010-03-03

Results First Submitted that Met QC Criteria

2015-05-22

Last Update Posted (ESTIMATED)

2015-06-09

First Posted (ESTIMATED)

2010-03-04

Results First Posted

2015-06-09

Last Verified

2015-05

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 (gemcitabine & pazopanib) Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle. Pazopanib 800 mg PO daily of each 28 day cycle.	DRUG: Gemcitabine DRUG: Pazopanib

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1 (gemcitabine & pazopanib)

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle. Pazopanib 800 mg PO daily of each 28 day cycle.

DRUG: Gemcitabine

DRUG: Pazopanib

Primary Outcome Measures	Measure Description	Time Frame
Response Rate by RECIST Criteria.	* Response rate = complete response + partial response per RECIST * Complete response - disappearance of all target and non-target lesions. * Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter	Follow-up was approximately 9 weeks

Primary Outcome Measures

Measure Description

Time Frame

Response Rate by RECIST Criteria.

* Response rate = complete response + partial response per RECIST * Complete response - disappearance of all target and non-target lesions. * Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter

Follow-up was approximately 9 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free Survival (PFS)	* PFS is defined as the duration of time from start of treatment to time to progression. * Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.	Follow-up was approximately 9 weeks
Median Survival		Length of follow-up was 35 weeks
Overall Survival		1 year

Secondary Outcome Measures

Measure Description

Time Frame

Progression-free Survival (PFS)

* PFS is defined as the duration of time from start of treatment to time to progression. * Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Follow-up was approximately 9 weeks

Median Survival

Length of follow-up was 35 weeks

Overall Survival

1 year

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.