Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer

NCT00091026 | Completed Phase 2 Results

• 11 other identifiers: NCI-2012-02622NCI-6580UCCRC-13200ACDR000038314513200A6580N01CM62204N01CM62203N01CM62201U01CA099118P30CA014599
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to 6 months

Secondary Outcomes (2)

• Progression-free Survival

  36 months

• Overall Survival

  36 months

Study Arms (2)

Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)

EXPERIMENTAL

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.

Biological: cetuximab; Drug: gemcitabine hydrochloride; Biological: bevacizumab

Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)

EXPERIMENTAL

Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.

Drug: gemcitabine hydrochloride; Biological: bevacizumab; Drug: erlotinib hydrochloride

Interventions

cetuximab BIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab); Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab); Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Advanced disease
• Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
• Not amenable to curative surgery or radiotherapy
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Pleural effusions and ascites are not considered measurable lesions
• No CNS disease, including primary brain tumors or brain metastasis
• No tumor invasion into the duodenum
• Performance status - ECOG 0-2
• More than 3 months
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• WBC ≥ 3,000/mm\^3
• No history of bleeding diatheses

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Gemcitabine; Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Hedy Kindler, MD
• Organization: University of Chicago

hkindler@medicine.bsd.uchicago.edu

(773) 702-0360

Study Officials

• Hedy Kindler

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: July 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 15, 2014
• Results First Posted: November 20, 2013

Record last verified: 2012-12

Locations

US (1)