- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114179
Capecitabine, Bevacizumab, and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine, bevacizumab, and radiotherapy followed by maintenance therapy comprising gemcitabine and bevacizumab to a historical control.
SECONDARY OBJECTIVES:
I. Determine the frequency of serious unacceptable adverse events in patients treated with this regimen.
II. Determine the response rate in patients treated with this regimen. III. Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study within 16 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Radiation Therapy Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the pancreas
- Locally advanced disease
- Unresectable disease
- All malignant disease must be encompassable within a single irradiation field
- Radiographically assessable disease
- Patients with biliary or gastroduodenal obstruction are eligible provided drainage or surgical bypass was performed prior to initiation of study treatment
- No evidence of gastric outlet obstruction
- No evidence of duodenal invasion on CT scan
- No evidence of metastatic disease in the major viscera
- No peritoneal seeding or ascites
- Performance status - Zubrod 0-1
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No evidence of bleeding diathesis
- ALT < 3 times upper limit of normal
- Bilirubin < 2.0 mg/dL
- INR ≤ 1.5
- No evidence of coagulopathy
- Creatinine clearance > 50 mL/min
- Urine protein < 1,000 mg by 24-hour urine collection (for patients with proteinuria ≥ 1+ by dipstick or urinalysis OR urine protein:creatinine ratio ≥ 1.0)
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
No arterial thromboembolic events within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Clinically significant peripheral artery disease
No unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [i.e., atrial fibrillation or paroxysmal supraventricular tachycardia])
- Patients with an atrial arrhythmia are eligible provided the condition is well controlled on stable medication
- No New York Heart Association class II-IV congestive heart failure
- No history of arteriovenous malformation
- No history of aneurysm
- No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg with medication)
- No other clinically significant cardiac disease
- No AIDS
- No significant infection
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Not pregnant
- No nursing during and for ≥ 3-4 months after completion of study treatment
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3-4 months after completion of study treatment
- No history of gastrointestinal fistula or perforation
- No other malignancy within the past two years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
- No significant traumatic injury within the past 4 weeks
- No serious nonhealing wound or ulcer
- No current healing fracture
- No known or suspected dihydropyrimidine dehydrogenase deficiency
- No other medical condition that would preclude study participation
- No concurrent interleukin-11
- No prior chemotherapy for pancreatic cancer
- More than 2 years since prior chemotherapy for another malignancy
- No prior radiotherapy to the planned irradiation field
- No concurrent intensity modulated radiotherapy
- No other concurrent radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior major surgical procedure or open biopsy
- More than 1 week since prior fine needle aspiration or core biopsy
- No prior organ transplantation
- No concurrent major surgical procedure
More than 30 days since prior and no concurrent cimetidine
- Concurrent ranitidine or a drug from another anti-ulcer class allowed
- More than 4 weeks since prior and no concurrent sorivudine or brivudine
No concurrent warfarin during chemoradiotherapy
- Concurrent warfarin allowed beginning 2 weeks after completion of chemoradiotherapy
- Concurrent low molecular weight heparin allowed (at any time during study participation)
- No other concurrent investigational agents
- No other concurrent cytotoxic agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab. Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later. Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Given IV
Other Names:
Given IV
Other Names:
Undergo radiotherapy
Other Names:
Undergo surgery
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival rate
Time Frame: 1 year
|
Will be estimated using the Kaplan-Meier method.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of patients developing grade 3 or greater adverse events as defined per CTCAE version 3.0
Time Frame: Up to 1 year
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Up to 1 year
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Progression-free survival
Time Frame: Up to 1 year
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Will be estimated using the Kaplan-Meier method.
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Up to 1 year
|
Response rate
Time Frame: Up to 1 year
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Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Crane, Radiation Therapy Oncology Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Antibodies
- Capecitabine
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCI-2012-02661 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000434846
- RTOG-0411 (Other Identifier: CTEP)
- U10CA021661 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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