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

University of Miami

Status

Completed

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine Hydrochloride

Biological: Cetuximab

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00448838

WIRB-20052717 (Other Identifier)

20057548

SCCC-2005141 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed pancreatic cancer
Locally advanced or metastatic disease
No active CNS metastases
- Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for > 3 weeks, are eligible

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