Clinical trial NCT00448838: Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official title: Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
stage II pancreatic cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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 outcomes:
measure: Toxicity
timeFrame: Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.
measure: Response rate (complete response and partial response)
timeFrame: After every 4th cycle; End of Treatment and Follow-up
measure: Duration of response
timeFrame: 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
measure: Overall survival
timeFrame: Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
measure: Time to progression
timeFrame: The time from the start of the treatment until the criteria for disease progression are met
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Caio Max S. Rocha Lima, MD
role: STUDY_CHAIR
References: