A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma
OBJECTIVES:
Primary
- To estimate the proportion of patients with resectable adenocarcinoma of the pancreas
alive at 2 years from the date of study registration after treatment with neoadjuvant
and adjuvant gemcitabine hydrochloride and erlotinib hydrochloride plus pancreatectomy.
Secondary
- To determine the resection rate (defined as the fraction of patients who proceed to
planned surgery with removal of primary tumor [R0/R1]) after neoadjuvant treatment with
gemcitabine hydrochloride and erlotinib hydrochloride.
- To estimate the time to disease progression/relapse in these patients.
- To evaluate the rate of R0, R1, and R2 resections in these patients.
- To evaluate the toxicity profile and feasibility of this regimen in these patients.
- To evaluate response rates in patients treated with this regimen.
- To identify molecular predictors of response to this regimen.
- To identify genetic profiles of pancreatic adenocarcinoma that may be associated with
response to neoadjuvant therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy:Patients receive gemcitabine hydrochloride IV over 30 minutes on
days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43
in the absence of disease progression or unacceptable toxicity.
- Surgery:At 3-6 weeks after completion of neoadjuvant therapy, patients undergo
pancreaticoduodenectomy.
- Adjuvant therapy:Beginning 5-10 weeks after surgery, patients receive gemcitabine
hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy.
Patients undergo blood and tumor tissue sample collection for correlative laboratory
studies. Studies include assessment of epithelial-mesenchymal transition (EMT) markers,
analysis of EGFR intron 1 polymorphism, and identification of genetic profiles by RNA
analysis.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreatic head or
uncinate process
- No tumors of the pancreatic neck, body, or tail
- No evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary
adenocarcinoma
- Localized, potentially resectable* tumor by chest x-ray or CT scan and abdominal CT
scan or MRI, as defined by the following:
- No evidence of tumor extension to the celiac axis, hepatic artery, or superior
mesenteric artery
- No evidence of tumor encasement or occlusion of the superior mesenteric vein
(SMV) or the SMV/portal vein confluence
- No evidence of visceral or peritoneal metastases NOTE: *Patients with borderline
resectable or marginally resectable pancreatic cancer are not eligible.
PATIENT CHARACTERISTICS:
- ECOG or Zubrod performance status 0-1
- WBC ≥ 2,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 2.5 mg/dL
- ALT and AST ≤ 2.5 times upper limit of normal
- Albumin ≥ 3.2 g/dL
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Baseline weight loss ≤ 15% of premorbid weight
- No active infection requiring intravenous antibiotics
- No other malignancy within the past 5 years except for nonmelanoma skin cancer or in
situ cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior EGFR-targeted therapy
- No prior therapy for pancreatic cancer
- No other concurrent investigational or commercial agents or therapies for pancreatic
cancer
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival at 2 years
Safety Issue:
No
Principal Investigator
Peter W.T. Pisters, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
Unspecified
Study ID:
CDR0000609871
NCT ID:
NCT00733746
Start Date:
April 2009
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage I pancreatic cancer
- stage II pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
| Surgical Oncology Associates | Newport News, Virginia 23606 |
| St. Francis Hospital Cancer Care Services | Indianapolis, Indiana 46237 |
