Preop Chemoradiation Resectable Pancreas
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- To assess disease free survival and overall survival
- To assess margin resection rate (R0 vs. R1) in these patients
- 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:
Drug Information available for:
Pancreatin
Pancrelipase
Gemcitabine
Gemcitabine hydrochloride
Bevacizumab
U.S. FDA Resources
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:
Drug: Gemcitabine
400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
Other Names:
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 chemoradiation.
- There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
- 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
- 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
- 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.
Exclusion Criteria:
- Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
- Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
- Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
- Clinically significant peripheral vascular disease.
- 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.
- Known presence of central nervous system or brain metastases.
- 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
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- 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.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of duodenal invasion
- Inability to comply with study and/or follow-up procedures
- Patients less than 18 years of age.
Contacts and Locations
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 May 22, 2013