Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Other: pharmacogenomic studies
Other: pharmacological study
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer|
- Six Month Survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
- Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
- Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR]) [ Time Frame: Evaluated using the first 6 courses of treatment ] [ Designated as safety issue: No ]
A confirmed tumor response is defined to be a CR or PR noted as
> the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
> Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters.
> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters.
- Duration of Response [ Time Frame: From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years ] [ Designated as safety issue: No ]Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.
- Progression-Free Survival [ Time Frame: Progression and survival status assessed every month, up to 2 years ] [ Designated as safety issue: No ]Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.
|Study Start Date:||October 2008|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Given POOther: pharmacogenomic studies
Optional correlative studiesOther: pharmacological study
Optional correlative studiesProcedure: positron emission tomography
Optional correlative studiesRadiation: fludeoxyglucose F 18
Optional correlative studiesOther: laboratory biomarker analysis
Optional correlative studies
I. To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib).
II. To determine the adverse events of this drug in these patients.
I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients.
Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Colorado|
|University of Colorado at Denver Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital|
|Nedlands, Western Australia, Australia, 6009|
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Wells Messersmith||Mayo Clinic|