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Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00766636 |
Primary Objective:
To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: Gemcitabine Radiation: Radiation Therapy Drug: Erlotinib Procedure: Surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas |
Estimated Enrollment: | 190 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Gemcitabine + Erlotinib without radiation
|
Drug: Gemcitabine
Arm A: 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Arm B: 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.
100 mg daily by mouth on days 1-36.
Procedure: Surgery
Surgical removal of the pancreas and duodenum
|
B: Experimental
Gemcitabine + Erlotinib with radiation
|
Drug: Gemcitabine
Arm A: 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Arm B: 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.
1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.
Drug: Erlotinib
100 mg daily by mouth on days 1-36.
Procedure: Surgery
Surgical removal of the pancreas and duodenum
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jason B. Fleming, MD | 713-745-0890 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jason B. Fleming, MD 713-745-0890 | |
Principal Investigator: Jason B. Fleming, MD |
Principal Investigator: | Jason B. Fleming, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Jason B. Fleming MD/Associate Professor ) |
Study ID Numbers: | 2008-0459 |
Study First Received: | October 3, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00766636 History of Changes |
Health Authority: | United States: Institutional Review Board |
Adenocarcinoma of the pancreatic head Pancreaticoduodenectomy Preoperative chemotherapy Chemoradiation Resectable pancreatic cancer |
Surgical removal of the pancreas and duodenum External-beam radiation therapy EBRT Gemcitabine Erlotinib |
Erlotinib Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents |
Pancrelipase Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Erlotinib Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |