Spots Global Cancer Trial Database for Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
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Trial Identification
Brief Title: Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official Title: A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma
Study ID: NCT00733746
Conditions
Study Description
Brief Summary: PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
Detailed Description: This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will be followed by exploratory laparotomy and pancreaticoduodenectomy. Patients will then receive postoperative chemotherapy consisting of gemcitabine plus erlotinib. Up to 123 patients will be accrued to this study, with the expectation that 78 patients will remain fully eligible and evaluable for the primary endpoint. The primary and secondary objectives for the study are listed below. Primary Objective: To estimate the proportion of patients alive at two years from the date of registration Secondary Objectives: 1. To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor \[R0/R1\]) following induction treatment with gemcitabine plus erlotinib 2. To estimate the time to disease progression/relapse 3. To evaluate the rate of R0, R1, and R2 resections (defined as per the 6th edition of the AJCC Cancer Staging Manual) in patients treated with preoperative gemcitabine plus erlotinib chemotherapy 4. To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib 5. To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib 6. To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib 7. To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy After completion of postoperative chemotherapy treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States
St. Vincent's Medical Center, Bridgeport, Connecticut, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida, United States
St. Francis Hospital Cancer Care Services, Indianapolis, Indiana, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Surgical Oncology Associates, Newport News, Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Peter W.T. Pisters, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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