Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT ID: NCT00448838

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-03-31

Brief Summary

RATIONALE: Monoclonal antibodies, such as 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. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.

Secondary

• Determine the complete response and partial response in patients treated with this regimen.
• Determine the time to progression in patients treated with this regimen.
• Determine the duration of response in patients treated with this regimen.
• Determine the survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a nonrandomized, open-label, pilot study.

Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2-4 hours on day 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; stage II pancreatic cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cetuximab

Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.

Intervention Type: BIOLOGICAL

Gemcitabine Hydrochloride

Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.

Intervention Type: DRUG

Other Intervention Names

C-225; Gemcitabine HCl

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 mg/dL
• Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases)
• AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases)
• Creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 90 days after completion of study treatment
• No significant history of uncontrolled cardiac disease, including any of the following:

• Uncontrolled hypertension
• Unstable angina
• Myocardial infarction within the past 6 months
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• No prior severe infusion reaction to a monoclonal antibody
• No active infection or fever ≥ 38.5°C within the past 3 days
• No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody
• No peripheral neuropathy ≥ grade 2
• No known HIV positivity
• No hepatitis B or C infection (active, previously treated, or both)
• No other medical condition, including mental illness or substance abuse, that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy, including surgery
• More than 30 days since prior investigational therapy
• More than 4 weeks since prior radiotherapy
• No prior radiotherapy to more than 25% of bone marrow
• More than 30 days since prior chemotherapy
• No prior chemotherapy for metastatic pancreatic cancer
• Prior fluoropyrimidine as a radiosensitizer allowed
• Prior gemcitabine hydrochloride in the adjuvant setting allowed
• No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway
• No prior allogeneic transplantation
• No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy
• No other concurrent treatment that targets the EGFR
• No other concurrent monoclonal antibody therapy
• No concurrent radiotherapy except for local control of bone pain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caio Max S. Rocha Lima, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SCCC-2005141

Identifier Type: OTHER

Identifier Source: secondary_id

WIRB-20052717

Identifier Type: OTHER

Identifier Source: secondary_id

20057548

Identifier Type: -

Identifier Source: org_study_id