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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00733746
First received: August 12, 2008
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery.


Condition Intervention Phase
Pancreatic Cancer
 Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resection rate [ Designated as safety issue: No ]
  • Relapse/progression-free survival [ Designated as safety issue: No ]
  • Adverse event profile [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Molecular and genetic profiles [ Designated as safety issue: No ]

Estimated Enrollment: 123
Study Start Date: April 2009
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733746

  Show 24 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Peter W.T. Pisters, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00733746     History of Changes
Other Study ID Numbers: CDR0000609871, ACOSOG-Z5041
Study First Received: August 12, 2008
Last Updated: February 13, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013