Pancreatic Cancer

Clinical Trial: Capecitabine, Bevacizumab, and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Condition	Intervention	Phase
adenocarcinoma of the pancreas stage III pancreatic cancer stage II pancreatic cancer	Drug: bevacizumab Drug: capecitabine Drug: gemcitabine Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: growth factor antagonist therapy Procedure: monoclonal antibody therapy Procedure: radiation therapy Procedure: radiosensitization	Phase II

MedlinePlus related topics: Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Capecitabine, Bevacizumab, and Radiotherapy Followed By Maintenance Therapy Comprising Gemcitabine and Bevacizumab in Patients With Unresectable Locally Advanced Pancreatic Cancer

Further Study Details:

OBJECTIVES: Primary

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

Determine the frequency of serious unacceptable adverse events in patients treated with this regimen.
Determine the response rate in patients treated with this regimen.
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. 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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

DISEASE CHARACTERISTICS:

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 duodenal invasion
No evidence of metastatic disease in the major viscera
No peritoneal seeding or ascites

PATIENT CHARACTERISTICS: Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No evidence of bleeding diathesis

Hepatic

ALT < 3 times upper limit of normal
Bilirubin < 2.0 mg/dL
INR ≤ 1.5
No evidence of coagulopathy

Renal

Creatinine < 1.5 mg/dL
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)

Cardiovascular

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

Immunologic

No AIDS
No significant infection
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

Other

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 other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for pancreatic cancer
More than 2 years since prior chemotherapy for another malignancy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the planned irradiation field
No concurrent intensity modulated radiotherapy
No other concurrent radiotherapy

Surgery

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

Other

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00114179

California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609, United States; Recruiting