Preop Chemoradiation Resectable Pancreas

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00336648
First received: June 13, 2006
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Primary Objective:

1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.

Secondary Objectives:

  1. To assess disease free survival and overall survival
  2. To assess margin resection rate (R0 vs. R1) in these patients
  3. To assess patterns of failure

Condition Intervention Phase
Pancreatic Neoplasms
Drug: Avastin (Bevacizumab)
Drug: Gemcitabine
Procedure: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients with Resection [ Time Frame: 8 weeks (+/- 2 days) after the completion of chemoradiation ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Avastin + Surgery
Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy
Drug: Avastin (Bevacizumab)
10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
Other Names:
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Gemcitabine
400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar
Procedure: Radiation Therapy
Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
Other Names:
  • RT
  • Radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 chemoradiation.
  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 greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening
  6. Hepatic function (endoscopic or percutaneous drainage as needed) Total bilirubin less than or equal to 2 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than or equal to 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.

Exclusion Criteria:

  1. Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
  2. Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
  3. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  4. History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
  5. Clinically significant peripheral vascular disease.
  6. Known history of bleeding diathesis coagulopathy. If patient has prior documented PT, INR then INR should be less than 2.0 (patients on anticoagulation for atrial fibrillation, other cardiac disorders, and for remote history of thrombosis are not excluded). Lab results should be within 2 weeks of patient enrollment.
  7. Known presence of central nervous system or brain metastases.
  8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  9. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
  10. Urine protein: creatinine ratio greater than 1.0 at screening; a 24 hour urine protein should be obtained and the level must be less than 1gm/24 hours in order for the patient to be eligible.
  11. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  12. Serious, non-healing wound, ulcer, or bone fracture
  13. Evidence of duodenal invasion
  14. Inability to comply with study and/or follow-up procedures
  15. Patients less than 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336648

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Douglas Evans, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00336648     History of Changes
Other Study ID Numbers: 2005-0784
Study First Received: June 13, 2006
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Neoplasms
Bevacizumab
Gemcitabine
Radiation Therapy
adenocarcinoma of the pancreatic head
adenocarcinoma of the uncinate process

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies, Monoclonal
Gemcitabine
Pancrelipase
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014