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A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

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 HospitalTulsa, Oklahoma  74136
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
CCOP - DaytonKettering, Ohio  45429
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Samaritan North Cancer Care CenterDayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
St. Vincent's Medical CenterBridgeport, Connecticut  06606
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Surgical Oncology AssociatesNewport News, Virginia  23606
St. Francis Hospital Cancer Care ServicesIndianapolis, Indiana  46237