Neoadjuvant Gemcitabine, Oxaliplatin, and Radiation Therapy for Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00426738
First received: January 24, 2007
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

Primary Objective

1.1 To determine the two-year disease-free survival in patients with resectable pancreatic cancer treated preoperatively with a combination of full-dose gemcitabine, oxaliplatin and concurrent radiation therapy.

Secondary Objectives

1.2 To determine the toxicity profile of this treatment regimen.

1.3 To determine the objective response rate, the surgical resectability rate, the time-to-treatment failure, patterns of treatment failure and overall survival of the proposed treatment.

1.4 To evaluate pathologic effects of neoadjuvant therapy.

1.5 To evaluate the utility of FDG-PET imaging in determining resp.

1.4 To evaluate pathologic effects of neoadjuvant therapy.

1.5 To evaluate the utility of FDG-PET imaging in determining response to preoperative therapy and predicting disease free survival.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine
Drug: Oxaliplatin
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Two year disease free survival rate [ Time Frame: Treatment course then follow-up period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Treatment course and then follow-up schedule. ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: Treatment course and follow-up schedule. ] [ Designated as safety issue: No ]
  • Pathological effects of neoadjuvant therapy [ Time Frame: Treatment course then follow-up schedule. ] [ Designated as safety issue: Yes ]
  • Evaluate the utility of FDGPET imaging in predicting disease free survival [ Time Frame: Treatment course then follow-up schedule. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2006
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.
    Other Name: Gemzar
    Drug: Oxaliplatin
    Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.
    Radiation: Radiation Therapy
    Radiation Therapy will be given daily, five times weekly (excluding holidays), starting on the first day of the first cycle of chemotherapy. Treatment will generally begin on a Monday. A Tuesday start will be allowed as long as the patient can be treated on Saturday of that week. On the days of chemotherapy, radiation therapy will be delivered after chemotherapy infusion. The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Determination of resectability is based on spiral CT with both oral and intravenous contrast enhancement. The patient's tumor is considered resectable if there are no distant metastases, a clear fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric vein/portal vein.
  • Patients considered borderline resectable per the NCCN criteria include patients with severe unilateral SMV/portal impingement, tumor abutment on the SMA, GDA encasement up to the origin at the hepatic artery, or colon invasion.

Note: Prior to treatment initiation, patients will be coded as resectable or borderline resectable.

Eligibility Criteria:

  • Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. Patients with neuroendocrine tumors are excluded.
  • Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
  • Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
  • Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
  • Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  • Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
  • Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
  • Patients must be aware of the investigational nature of the therapy and provide written informed consent.
  • Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
  • Patients must not have used any investigational agent in the month before enrollment into the study.
  • Pretreatment Evaluation
  • Complete history and physical examination including weight and Zubrod performance status to be completed within 2 weeks of registration.
  • CBC with differential, platelets, serum chemistry panel (to include albumin, alkaline phosphatase, ALT or AST, glucose, total bilirubin, creatinine, BUN, electrolytes), and CEA/CA 19-9 within 2 weeks of registration.
  • Diagnostic helical CT of the abdomen with oral and intravenous contrast to be completed within 4 weeks of registration. Patients in whom IV contrast is contraindicated based on severe allergy or decreased renal function should have an MRI scan of the abdomen.
  • Diagnostic helical CT scan of the chest.
  • FDG-PET/CT scan within 4 weeks of registration, if available. (This is not required but desired.)
  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: NCT00426738

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
University of Michigan
Investigators
Principal Investigator: Joseph Herman, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00426738     History of Changes
Other Study ID Numbers: J-0686, NA_00003461
Study First Received: January 24, 2007
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
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
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014