Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
OBJECTIVES:
Primary
- Determine the progression-free survival rate in patients with unresectable, locally
advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy
comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either
surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.
Secondary
- Determine the toxicity and tolerability of this regimen in these patients.
- Determine overall survival and progression-free survival.
- Determine the response rate in these patients.
- Determine the response duration (defined as the time from first observation response to
the time of progressive disease) in patients who achieve at least a partial response to
treatment.
- Determine the biomarker response of CA19-9.
OUTLINE: This is an open-label study.
- Neoadjuvant therapy: 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 hours
on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic
disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant
therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy
(by choice); patients with unresectable disease proceed to chemoradiotherapy.
- Surgery: Patients undergo surgical resection with the Whipple procedure.
- Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on
days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or radiologically confirmed pancreatic cancer, meeting both of the
following criteria:
- Locally advanced, nonmetastatic disease
- Surgically unresectable disease
- Measurable disease, defined as unidimensionally measurable by physical exam or
imaging study
- The following are considered nonmeasurable disease:
- Bone-only disease
- Pleural or peritoneal effusions
- CNS lesions
- Irradiated lesions in the absence of progression after radiotherapy
- No history or evidence of CNS disease
- No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 90 days after
completion of study therapy
- No acute hepatitis
- No known HIV positivity
- No active or uncontrolled infection
- No significant history of uncontrolled cardiac disease, including, but not limited
to, 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 second malignancy other than nonmelanoma skin cancer
- No history of deep vein thrombosis
- No history of bleeding diathesis or coagulopathy
- No other severe concurrent disease, mental incapacitation, or psychiatric illness
that would preclude study participation
PRIOR CONCURRENT THERAPY:
- No prior therapy for pancreatic cancer
- No prior therapy specifically targeting the epidermal growth factor-receptor pathway
- No major surgical procedure or open biopsy within the past 28 days
- No prior radiotherapy or chemotherapy
- No prior or concurrent full-dose anticoagulants or thrombolytics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival at 6 months
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Andrew S. Kraft, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of South Carolina
Authority:
United States: Federal Government
Study ID:
CDR0000518313
NCT ID:
NCT00408564
Start Date:
January 2006
Completion Date:
April 2013
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage II pancreatic cancer
- stage III pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
