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Phase II Randomized Study of Adjuvant Therapy Comprising Bevacizumab Versus Cetuximab in Combination With Gemcitabine Hydrochloride, Capecitabine, and Radiotherapy in Patients With Completely Resected Carcinoma of the Pancreas
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Bevacizumab or Cetuximab Combined With Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
Basic Trial Information
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Protocol IDs
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Phase II
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Biomarker/Laboratory analysis, Treatment
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Closed
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18 and over
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NCI
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ECOG-E2204 CALGB-ECOG-E2204, SWOG-ECOG-E2204, NCCTG-ECOG-E2204, E2204, NCT00305877
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Special Category:
NCI Web site featured trial, NCI - CMS pilot project trial 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.
Entry 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
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
Patient Characteristics:
- ECOG performance status 0-2
- WBC ≥ 3,000/mm3
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- 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
Expected Enrollment 126A total of 126 patients will be accrued for this study. Outcomes Primary Outcome(s)Toxicity
Secondary Outcome(s)Overall and disease-free survival Correlation between biomarkers (changes in serum alphiregulin and TGF alpha) and outcome in patients treated with cetuximab
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.
Trial Contact Information
Trial Lead Organizations Eastern Cooperative Oncology Group | | | Jordan Berlin, MD, Protocol chair | | | |
Cancer and Leukemia Group B | | | Arthur William Blackstock, MD, Protocol chair | | Ph: 336-713-6501; 800-446-2255 |
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Southwest Oncology Group | | | Andrew Lowy, MD, Protocol chair | | | |
North Central Cancer Treatment Group | | | Robert McWilliams, MD, Protocol chair | | | |
Related Information Featured trial article
Registry Information | | Official Title | | An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected Pancreatic Carcinoma | | Trial Start Date | | 2006-02-17 | | Trial Completion Date | | 2008-08-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00305877 | | Date Submitted to PDQ | | 2005-11-28 | | Information Last Verified | | 2008-10-22 | | NCI Grant/Contract Number | | CA21115 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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