Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01206296|
Recruitment Status : Terminated (Study suspended)
First Posted : September 21, 2010
Last Update Posted : December 9, 2015
This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.
The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma.
The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Intraperitoneal Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Intraperitoneal Gemcitabine
Drug: Intraperitoneal Gemcitabine
Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2
Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles
- Grade III and IV Complications [ Time Frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer ]Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206296
|United States, District of Columbia|
|Washington Cancer Institute at MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Lana Bijelic, MD||Washington Hospital Center|