Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.

Secondary Objectives:

• To assess disease free survival

• To assess overall survival

• To assess patterns of local and distant failure

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.

2. 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.

3. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to treatment

4. There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.

5. 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

6. 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

7. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.

8. 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.

9. Patients must sign a study-specific consent form, which is attached to this protocol.

Exclusion Criteria:

1. Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.

2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure

3. Known presence of central nervous system or brain metastases

4. Inability to comply with study and/or follow-up procedures

5. Patients < 18 years of age.