NCT00336648

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.3 years

First QC Date

June 13, 2006

Last Update Submit

July 26, 2012

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic NeoplasmsBevacizumabGemcitabineRadiation Therapyadenocarcinoma of the pancreatic headadenocarcinoma of the uncinate process

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Resection

    8 weeks (+/- 2 days) after the completion of chemoradiation

Study Arms (1)

Gemcitabine + Avastin + Surgery

EXPERIMENTAL

Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy

Drug: Avastin (Bevacizumab)Drug: GemcitabineProcedure: Radiation Therapy

Interventions

Avastin (Bevacizumab)DRUG

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.

Also known as: Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Gemcitabine + Avastin + Surgery
GemcitabineDRUG

400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)

Also known as: Gemcitabine Hydrochloride, Gemzar
Gemcitabine + Avastin + Surgery
Radiation TherapyPROCEDURE

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)

Also known as: RT, Radiotherapy
Gemcitabine + Avastin + Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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.

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

BevacizumabGemcitabineRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Douglas Evans, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2007

Study Completion

July 1, 2008

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)