Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00047710
First received: October 14, 2002
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.


Condition Intervention Phase
Pancreatic Cancer
Drug: Bevacizumab
Drug: Capecitabine
Radiation: Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety of combination Radiation, Bevacizumab, and Capecitabine. [ Time Frame: 6 weeks after the completion of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the local tumor response and median survival in patients treated with the above regimen. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
  • To evaluate VEGF serum levels before and after anti-VEGF therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
  • To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
  • To evaluate quality of life in patients receiving this therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Radiation, Bevacizumab, and Capecitabine
Drug: Bevacizumab
Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Capecitabine
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Other Name: Xeloda
Radiation: Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Other Name: XRT

Detailed Description:

This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
  • Patients with nonmetastatic, unresectable, disease are eligible.
  • Patients with regional nodal disease are eligible.
  • Karnofsky performance status >/=70.
  • No upper age restriction.
  • Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
  • Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
  • Adequate bilateral renal function.
  • Serum creatinine <1.5 mg/dl.
  • Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)</=5 times upper limit of normal.
  • Sexually active men must practice contraception during study.
  • Patients must sign study-specific consent form.

Exclusion Criteria:

  • History or evidence upon physical examination of CNS disease.
  • Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
  • Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
  • Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
  • Pregnancy or lactation.
  • Proteinuria at baseline or impairment of renal function.
  • Serious, nonhealing wound, ulcer, or bone fracture.
  • Evidence of bleeding diathesis or coagulopathy
  • Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0.
  • History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations.
  • Serous concomitant medical or psychiatric disorders.
  • Cohort receiving Capecitabine
  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: NCT00047710

Locations
United States, Texas
University of Texas MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Christopher H. Crane, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00047710     History of Changes
Other Study ID Numbers: ID02-146
Study First Received: October 14, 2002
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
pancreatic cancer
pancreas cancer
pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Fluorouracil
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014