Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

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

Outcome 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

Safety Issue:

No

Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20057548

NCT ID:

NCT00448838

Start Date:

May 2006

Completion Date:

March 2011

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • stage II pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136