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

December 14, 2016 updated by: University of Miami

Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Pancreatic Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Miami, Florida, United States, 33136
    - University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival Time Frame: The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals	The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method	The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity Time Frame: Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.		Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.
Response rate (complete response and partial response) Time Frame: After every 4th cycle; End of Treatment and Follow-up	The response rate will be determined by the RECIST criteria. After every 4th cycle; End of Treatment and Follow-up	After every 4th cycle; End of Treatment and Follow-up
Duration of response Time Frame: The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented	the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started	The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented
Overall survival Time Frame: Overall survival will also be estimated using the product-limit method of Kaplan-Meier.	Overall survival will also be estimated using the product-limit method of Kaplan-Meier.	Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
Time to progression Time Frame: The time from the start of the treatment until the criteria for disease progression are met	The time from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started (also referred to in the RECIST criteria as duration of stable disease).	The time from the start of the treatment until the criteria for disease progression are met

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria