Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started

Description

Summary

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. 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.

Official Title

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

Details

This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will be followed by exploratory laparotomy and pancreaticoduodenectomy. Patients will then receive postoperative chemotherapy consisting of gemcitabine plus erlotinib. Up to 123 patients will be accrued to this study, with the expectation that 78 patients will remain fully eligible and evaluable for the primary endpoint. The primary and secondary objectives for the study are listed below.

Primary Objective:

To estimate the proportion of patients alive at two years from the date of registration

Secondary Objectives:

  1. To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor [R0/R1]) following induction treatment with gemcitabine plus erlotinib
  2. To estimate the time to disease progression/relapse
  3. To evaluate the rate of R0, R1, and R2 resections (defined as per the 6th edition of the AJCC Cancer Staging Manual) in patients treated with preoperative gemcitabine plus erlotinib chemotherapy
  4. To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib
  5. To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib
  6. To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib
  7. To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy

After completion of postoperative chemotherapy treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.

Keywords

Pancreatic Cancer adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer Pancreatic Neoplasms Gemcitabine Erlotinib Hydrochloride gemcitabine hydrochloride therapeutic conventional surgery Neoadjuvant therapy + Surgery + Adjuvant therapy

Eligibility

For people ages 18 years and up

Eligibility Criteria:

  1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process.

NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible.Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible.

  1. Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging:
  2. No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery
  3. No evidence of tumor encasement or occlusion of the superior mesenteric vein(SMV) or the SMV/portal vein confluence
  4. No evidence of visceral or peritoneal metastases

NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging criteria outlined above.

  1. ≥ 18 years of age
  2. ECOG/Zubrod performance status of 0 or 1
  3. Baseline weight loss ≤ 15% of premorbid weight
  4. Patient must have adequate hematologic, renal, and hepatic function as defined by:
  5. WBC ≥ 2,000 cells/mm³
  6. ANC ≥ 1,500 cells/mm³
  7. Platelets ≥ 100,000 cells/mm³
  8. Serum bilirubin ≤ 2.5 mg/dL
  9. Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min(24 hour urine collection)
  10. ALT < 2.5 times upper limit of normal (ULN)
  11. AST < 2.5 times ULN
  12. Albumin ≥ 3.2 g/dl
  13. No history of the following:
  14. Prior EGFR targeted therapy or therapy for pancreatic cancer
  15. Active infection requiring intravenous antibiotics at the time of registration
  16. Non-pregnant and non-breast feeding. Female participants of child bearing potential must have a negative urine or serum pregnancy test prior to registration.Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth control while receiving study therapy.
  17. No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

Locations

  • Rebecca and John Moores UCSD Cancer Center
    La Jolla California 92093-0658 United States
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    Orange California 92868 United States
  • Kaiser Permanente Medical Center - Los Angeles
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT00733746
Phase
Phase 2
Study Type
Interventional
Last Updated
May 2017