Status:
TERMINATED
Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 chem...
Detailed Description
The Study Drugs: Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. Erlotinib is designed to block the activity of a protein found on the surface of ...
Eligibility 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00766636
Start Date
September 1 2008
Last Update
May 19 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030