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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00766636 |
Primary Objective To assess margin positive resection rate (R1 resection rate) 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 Objective
Condition | Intervention | Phase |
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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 |
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A: Experimental
Gemcitabine + Erlotinib without radiation
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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
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B: Experimental
Gemcitabine + Erlotinib with radiation
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
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: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00766636 |
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 Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |