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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00448838
First received: March 15, 2007
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Biological: Cetuximab
Drug: Gemcitabine Hydrochloride
Drug: Oxaliplatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Response rate (complete response and partial response) [ Time Frame: After every 4th cycle; End of Treatment and Follow-up ] [ Designated as safety issue: No ]
    The response rate will be determined by the RECIST criteria. 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 ] [ Designated as safety issue: No ]
    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

  • Overall survival [ Time Frame: Overall survival will also be estimated using the product-limit method of Kaplan-Meier. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 42
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 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.
    Other Name: C-225
    Drug: Gemcitabine Hydrochloride
    Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.
    Other Name: Gemcitabine HCl
    Drug: Oxaliplatin
    Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448838

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Caio Max S. Rocha Lima, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00448838     History of Changes
Other Study ID Numbers: UMIAMI-20057548, SCCC-2005141, WIRB-20052717
Study First Received: March 15, 2007
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014