Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00766636

Purpose

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

To assess disease free survival
To assess overall survival
To assess patterns of local and distant failure

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Radiation: Radiation Therapy Drug: Erlotinib Procedure: Surgery	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Pancrelipase Ultrase

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To compare the benefits of the chemotherapy combination of gemcitabine and erlotinib with and without radiation therapy, followed by surgical removal of the pancreas and duodenum. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

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. Drug: Erlotinib 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. Radiation: Radiation Therapy 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

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.

Drug: Erlotinib

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.

Radiation: Radiation Therapy

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to treatment
There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
Adequate renal, and bone marrow function: • Leukocytes >= 3,000/uL • Absolute neutrophil count >= 1,500/uL • Platelets >= 100,000/Ul • Serum creatinine <= 2.0 mg/dL
Hepatic function (endoscopic or percutaneous drainage as needed) • Total bilirubin < = 2 X institutional upper limits of normal (ULN) • AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN
Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
Patients must sign a study-specific consent form, which is attached to this protocol.

Exclusion:

Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure
Known presence of central nervous system or brain metastases
Inability to comply with study and/or follow-up procedures
Patients < 18 years of age.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766636

Contacts

Contact: Jason B. Fleming, MD

713-745-0890

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Jason B. Fleming, MD

UT MD Anderson Cancer Center

More Information

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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

Keywords provided by M.D. Anderson Cancer Center:

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

Study placed in the following topic categories:

Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Adenocarcinoma
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009