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

NCT00766636 | Terminated Phase 2 Results DMC

• 1 other identifier: 2008-0459
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.

  Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report

  Following resection performed at time of surgery, day 36 of treatment +/- 5 days

Study Arms (2)

Gemcitabine + Erlotinib Without Radiation

EXPERIMENTAL

Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 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. Erlotinib 100 mg daily by mouth on days 1-42. Surgical removal of the pancreas and duodenum.

Drug: Gemcitabine; Drug: Erlotinib; Procedure: Surgery

Gemcitabine + Erlotinib With Radiation

EXPERIMENTAL

Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 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. Erlotinib 100 mg daily by mouth on days 1-42. 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. Surgical removal of the pancreas and duodenum.

Drug: Gemcitabine; Radiation: Radiation Therapy; Drug: Erlotinib; Procedure: Surgery

Interventions

Gemcitabine DRUG

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.

Also known as: Gemzar

Gemcitabine + Erlotinib With Radiation; Gemcitabine + Erlotinib Without Radiation

Radiation Therapy RADIATION

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.

Also known as: RT, Radiotherapy, External Beam Radiation Therapy, EBRT

Gemcitabine + Erlotinib With Radiation

Erlotinib DRUG

100 mg daily by mouth on days 1-42.

Also known as: Erlotinib Hydrochloride, OSI-774, Tarceva

Gemcitabine + Erlotinib With Radiation; Gemcitabine + Erlotinib Without Radiation

Surgery PROCEDURE

Surgical removal of the pancreas and duodenum

Also known as: pancreaticoduodenectomy, resection

Gemcitabine + Erlotinib With Radiation; Gemcitabine + Erlotinib Without Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy; Erlotinib Hydrochloride; Surgical Procedures, Operative; Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digestive System Surgical Procedures

Results Point of Contact

• Title: Jason B. Fleming, MD / Surgical Oncology
• Organization: University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-2300

Study Officials

• Jason B. Fleming, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2012
• Last Updated: May 19, 2016
• Results First Posted: September 18, 2015

Record last verified: 2015-08

Locations

US (1)