AzTrials
AzTrials

Pancreatic CancerNCT00448838

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

A study testing Cetuximab, Gemcitabine Hydrochloride and Oxaliplatin in people with Pancreatic Cancer, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Cetuximab, Gemcitabine Hydrochloride and Oxaliplatin
Type of treatment
Injection or infusion
How many people
42 participants
Where
1 siteUnited States
Study dates
May 2006to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, stage II pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabBiological

    Also called C-225

    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.

  • Gemcitabine HydrochlorideDrug

    Also called Gemcitabine HCl

    Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.

  • OxaliplatinDrug

    Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    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

    Measured: 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 (5)

  1. Toxicity

    Measured: Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.

  2. Response rate (complete response and partial response)

    The response rate will be determined by the RECIST criteria. After every 4th cycle; End of Treatment and Follow-up

    Measured: After every 4th cycle; End of Treatment and Follow-up

  3. Duration of response

    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

    Measured: 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

  4. Overall survival

    Overall survival will also be estimated using the product-limit method of Kaplan-Meier.

    Measured: Overall survival will also be estimated using the product-limit method of Kaplan-Meier.

  5. Time to progression

    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).

    Measured: The time from the start of the treatment until the criteria for disease progression are met

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2007 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2007
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448838
Sponsor's protocol ID
20057548
Other IDs
SCCC-2005141, WIRB-20052717
Status last verified
Dec 2016
First submitted
15 Mar 2007
Last updated
15 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cetuximab, Gemcitabine Hydrochloride and Oxaliplatin in people with Pancreatic Cancer, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in