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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448838
• Other study ID #: 20057548
• Secondary ID: SCCC-2005141WIRB
• Status: Completed
• Phase: N/A
• First received: March 15, 2007
• Last updated: December 14, 2016
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Drug:
• Gemcitabine Hydrochloride
Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.
• Oxaliplatin
Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	Toxicity		Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.	Yes
Secondary	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	After every 4th cycle; End of Treatment and Follow-up	No
Secondary	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	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	No
Secondary	Overall survival	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.	No
Secondary	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).	The time from the start of the treatment until the criteria for disease progression are met	No