Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma

This study has been withdrawn prior to enrollment.
(study withdrawn due to lack of enrollment)
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00728000
First received: July 31, 2008
Last updated: April 24, 2009
Last verified: April 2009
  Purpose

The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.


Condition Intervention Phase
Pancreatic Adenocarcinoma
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable. [ Time Frame: 9-10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DFS, PFS, OS and TD will be observed on each patient and censored at the end of the study. Measurements of toxicity are categorical variables. All numerical variables will be summarized by mean +- standard deviation (STD) and/or median (range) [ Time Frame: 9-10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy regimen
Gemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily.
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
Other Name: Gemzar®
Drug: Oxaliplatin
100mg/m2 IV on days 1 and 15 given over 120 mins.
Other Name: Eloxatin
Drug: Erlotinib
100mg/day PO on days 1-14 and 15-28
Other Name: Tarceva

Detailed Description:

Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with endocrine tumors or lymphoma of the pancreas are ineligible.
  • Patients must have locally advanced disease that is considered to be "borderline" surgically resectable (see Section 4.0). Patients with metastatic disease or grossly resectable disease on presentation are ineligible.
  • Patients must have measurable disease prior to starting this study. Patients with primarily non-measurable disease, including lesions to small to be characterized, effusions, ascites, diffuse bone disease, diffuse skin disease, leptomeningeal disease, lymphangitis, pneumonitis or disease measured by indirect or biochemical means, are not eligible. Testing for measurable disease must have been completed 28 days prior to registration.
  • Patients must consent to utilization of tissue for research in this protocol. Tissue will be evaluated via immunohistochemical staining for deoxycytidine kinase, ERCC-1 and ERCC-2 (XPD). Patients may be asked if they are willing to allow their tissue to be used for future studies that are not defined in this protocol. Disallowing the use of tissue for future studies does not limit eligibility in this protocol.
  • Patients must fulfill the required initial laboratory data to be obtained within 28 days prior to registration: AGC ≥ 1,500cells/μL, Platelet ≥ 100,000cells/μL, Hgb > 8.0 g/dl, Bilirubin ≤ 2.0 X IULN, Serum Creatinine ≤ 2.0mg/dL, AST(SGOT) ≤ 2.5x IULN, ALT(SGPT) ≤ 2.5x IULN, CA19-9 (any value),
  • Patients must have an ECOG/Zubrod performance status of 0-2.
  • Patients must be able to read and understand English in order to participate in this study, or have a certified translator present.
  • Due to the potentially harmful effects of chemotherapy on a developing fetus, patients who are pregnant are planning to become pregnant, or who are lactating should not participate in this study.
  • Women of childbearing potential must have a negative pregnancy test.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  • All patients must be informed of the investigational nature of this study and must sign, date and give written consent in accordance with institutional and federal guidelines.
  • All patients must be18 years of age or older to participate.

Exclusion Criteria:

  • Patients with known brain metastases are ineligible. Brain imaging studies are not required for eligible patients with no neurologic signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
  • Patients who have had prior surgery for their pancreatic carcinoma are not eligible for this study. This does not include patients who have had cytologic brushing, fine needle aspiration or core biopsy of their tumor for diagnostic purposes.
  • Patients must not have received prior chemotherapy, radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for pancreatic cancer.
  • Patients must not have received prior erlotinib or other therapies that target EGFR. Patients must not have received prior tyrosine kinase inhibitors.
  • Have a significant history of uncontrolled cardiac disease including uncontrolled hypertension, unstable angina or uncontrolled congestive heart failure.
  • Have a significant history of intersitital lung disease
  • Have a significant history of peripheral neuropathy (grade must be <1) or mononeuropathy multiplex.
  • Have temperature >101.30 F or active infection
  • No other history of malignancy is allowed except for the following:

adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.

  • There must be no other plans for the patient to receive concurrent chemotherapy, radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for the treatment of their cancer while on protocol.
  • Due to the undetermined effect of chemotherapy in patients with HIV infection and the potential for serious interaction with anti-HIV medications, patients who are known to be infected with HIV are not eligible for this study. An HIV test is not required to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728000

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Sanofi
Investigators
Principal Investigator: Leslie Oleksowicz, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Leslie Oleksowicz, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00728000     History of Changes
Other Study ID Numbers: OX-06-030, OX-06-030
Study First Received: July 31, 2008
Last Updated: April 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Pancreatic Cancer

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

ClinicalTrials.gov processed this record on October 22, 2014