Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genentech, Inc.
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
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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:
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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, Inc.
Investigators
| Principal Investigator: | Christopher H. Crane, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| 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 Bevacizumab Capecitabine |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016