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Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas

NCT00326911•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient has provided signed written informed consent.
•The patient is ≥18 years of age.
•The patient has histologically or cytologically-confirmed pancreatic adenocarcinoma not amenable to curative treatment with surgery or has documented or suspected extrapancreatic metastases.
•The patient has either (a) measurable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST) or (b) non-measurable disease with an elevated baseline CA19-9 level (≥2 x the upper limit of normal \[ULN\]).
•The patient's Eastern Cooperative Oncology Group (ECOG) performance status is ≤2.
•The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥1500/mm3 and a platelet count ≥100,000/mm3 obtained within 2 weeks prior to the first dose of study medication.
•The patient has adequate hepatic function as defined by a total bilirubin ≤2.0 mg/dL and transaminases ≤5.0 x ULN obtained within 2 weeks prior to the first dose of study medication.
•The patient has adequate renal function as defined by serum creatinine ≤2.0 x ULN and urine dipstick for proteinuria ≤1+ obtained within 2 weeks prior to the first dose of study medication. If urine dipstick is ≥2+, then a 24-hour urine for protein must demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study. Urinalysis is also acceptable.
•If the patient is on full-dose anticoagulation therapy (eg, warfarin or low molecular weight \[LMW\] heparin), the following criteria must be met:
•* The patient has an in-range International Normalized Ratio (\[INR\]usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of LMW heparin
+6 more criteria

Exclusion Criteria

•Endocrine tumors or lymphoma of the pancreas
•Known brain metastases
•Prior therapy with an epidermal growth factor receptor (EGFR) inhibitor or vascular endothelial growth factor (VEGF) inhibitor
•Prior chemotherapy, hormonal therapy, or radiation therapy for advanced pancreatic cancer, patients who received chemotherapy and/or radiation therapy in the adjuvant setting will be eligible as long as the adjuvant therapy was completed \>6 months prior
•Concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix
•Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
•Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
•History of arterial thrombotic events within 9 months
•History of uncontrolled hypertension (\>150/100 mmHg) not on a stable regimen of anti-hypertensive therapy
•History of significant bleeding events or upper or lower gastrointestinal bleeding within 9 months
+4 more criteria

Locations (16)

ImClone Investigational Site

Jonesboro, Arkansas, United States

ImClone Investigational Site

San Francisco, California, United States

ImClone Investigational Site

Stamford, Connecticut, United States

ImClone Investigational Site

Miami, Florida, United States

ImClone Investigational Site

Orlando, Florida, United States

ImClone Investigational Site

Orlando, Florida, United States

ImClone Investigational Site

Atlanta, Georgia, United States

ImClone Investigational Site

Augusta, Georgia, United States

ImClone Investigational Site

Marietta, Georgia, United States

ImClone Investigational Site

Metairie, Louisiana, United States

Key Dates

Start Date

May 1, 2006

Primary Completion Date

October 1, 2008

Completion Date

December 1, 2008

Last Updated

May 25, 2011

Enrollment

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

cetuximab

BIOLOGICAL

bevacizumab

BIOLOGICAL

gemcitabine

DRUG

cetuximab

BIOLOGICAL

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

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Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer