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

NCT ID: NCT00326911

Last Updated: 2011-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-12-31

Brief 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

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cetuximab + bevacizumab + gemcitabine

Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. All medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1

bevacizumab

Intervention Type: BIOLOGICAL

10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.

gemcitabine

Intervention Type: DRUG

1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.

cetuximab

Intervention Type: BIOLOGICAL

I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

cetuximab + bevacizumab

Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Group Type: ACTIVE_COMPARATOR

cetuximab

Intervention Type: BIOLOGICAL

I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1

bevacizumab

Intervention Type: BIOLOGICAL

10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.

cetuximab

Intervention Type: BIOLOGICAL

I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

Interventions

cetuximab

I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1

Intervention Type: BIOLOGICAL

bevacizumab

10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.

Intervention Type: BIOLOGICAL

gemcitabine

1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.

Intervention Type: DRUG

cetuximab

I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

Intervention Type: BIOLOGICAL

Other Intervention Names

Erbitux®; Avastin®; Gemzar®; Erbitux®

Eligibility Criteria

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
• The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• If the patient is not on full-dose anticoagulation therapy, the following criteria must be met:

• The patient has adequate coagulation function as defined by INR ≤1.5
• The patient has a partial thromboplastin (PTT) ≤ULN obtained within 2 weeks prior to the first dose of study medication
• If a woman, the patient agrees to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. If a male and sexually active, the patient agrees to use effective contraception.
• The patient is accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.

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
• History of gastrointestinal perforation within 12 months
• Serious non-healing wound ulcer, bone fracture, or major surgical procedure with 28 days
• If a woman, is pregnant or lactating
• An employee of the investigator or study center as well as family members of the employees

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

ImClone LLC

Principal Investigators

E-mail: ClinicalTrials@ ImClone.com

Role: STUDY_CHAIR

Eli Lilly and Company

Locations

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

ImClone Investigational Site

Billings, Montana, United States

ImClone Investigational Site

Concord, North Carolina, United States

ImClone Investigational Site

Philadelphia, Pennsylvania, United States

ImClone Investigational Site

Charleston, South Carolina, United States

ImClone Investigational Site

Arlington, Texas, United States

ImClone Investigational Site

Dallas, Texas, United States

Countries

United States

References

Ko AH, Youssoufian H, Gurtler J, Dicke K, Kayaleh O, Lenz HJ, Keaton M, Katz T, Ballal S, Rowinsky EK. A phase II randomized study of cetuximab and bevacizumab alone or in combination with gemcitabine as first-line therapy for metastatic pancreatic adenocarcinoma. Invest New Drugs. 2012 Aug;30(4):1597-606. doi: 10.1007/s10637-011-9691-8. Epub 2011 Jun 1.

Reference Type: DERIVED

PMID: 21629990 (View on PubMed)

Other Identifiers

CP02-0555

Identifier Type: -

Identifier Source: org_study_id