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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI, Other	CDR0000462441 ECOG-E2204, CALGB-ECOG-E2204, SWOG-ECOG-E2204, NCCTG-ECOG-E2204, NCT00305877

Trial Description

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab and cetuximab, 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 tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery.

Further Study Information

OBJECTIVES:

Primary

• Compare the toxicity profile of adjuvant therapy comprising bevacizumab vs cetuximab in combination with gemcitabine hydrochloride, capecitabine, and radiotherapy in patients with completely resected carcinoma of the pancreas.

• Compare the safety profile of bevacizumab vs cetuximab in combination with gemcitabine hydrochloride in these regimens.

• Obtain tissue specimens from these patients for correlative studies and further evaluations.

Secondary

• Compare disease-free and overall survival of patients treated with these regimens.

• Compare the safety profile of these regimens in these patients.

• Compare the 2-year survival rate in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).

• Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Tumor samples are analyzed for epidermal growth factor receptor (EGFR) status and microvessel density.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed carcinoma of the pancreas

• Underwent prior surgical resection of all gross disease more than 4 but no more than 8 weeks ago

• R0 (surgical margins clear) or R1 (microscopic involvement of margins) resection

• No R2 resection

• No acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, or carcinosarcoma

• No known metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin normal

• AST/ALT ≤ 2.5 times upper limit of normal (ULN)

• Creatinine normal OR

• Creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab, or other agents used in study

• No cardiac arrhythmia

• No known HIV infection

• No unhealed wound

• No psychiatric or addictive disorders or other condition that would preclude study participation

• No history of transient ischemic attack or cerebrovascular accident

• No arterial thromboembolic event within the past year

• No unstable angina within the past year

• No myocardial infarction within the past year

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior surgery

• No prior chemotherapy or radiotherapy for pancreatic cancer

• No prior epidermal growth factor receptor or vascular epithelial growth factor inhibitors

• No other concurrent investigational agents

• No concurrent full-dose anticoagulation

• No concurrent intensity-modulated radiotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Jordan D. Berlin

Study Chair

Arthur William Blackstock

Study Chair

Andrew M. Lowy

Study Chair

Robert McWilliams

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00305877
Information obtained from ClinicalTrials.gov on December 06, 2009

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