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Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00408564
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 6, 2006
First Posted Date  ICMJE December 7, 2006
Results First Submitted Date  ICMJE May 23, 2018
Results First Posted Date  ICMJE July 23, 2018
Last Update Posted Date July 23, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
Progression-free Survival at 6 Months [ Time Frame: up to 46 weeks after the start of study treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2006)
Progression-free Survival at 6 Months
Change History Complete list of historical versions of study NCT00408564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Number of Participants With Grade 3-4 Adverse Events Reported [ Time Frame: from start of study treatment until end of study visit, about 30 weeks ]
  • Overall Survival [ Time Frame: up to 46 weeks after the start of study treatment ]
  • Response Rate [ Time Frame: up to 46 weeks after the start of study treatment ]
    defined as the total number of subjects whose best response is PR or CR.
  • Response Duration in Patients With at Least Partial Response to Treatment [ Time Frame: up to 46 weeks after the start of study treatment ]
  • Determine the Biomarker Response of CA 19-9 to Therapy [ Time Frame: from start up treatment to one year after end of treatment, up to 81 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2006)
  • Toxicity
  • Overall survival and progression-free survival
  • Response Rate
  • Response duration in patients with at least partial response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

  • Determine the progression-free survival rate in patients with unresectable, locally advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.

Secondary

  • Determine the toxicity and tolerability of this regimen in these patients.
  • Determine overall survival and progression-free survival.
  • Determine the response rate in these patients.
  • Determine the response duration (defined as the time from first observation response to the time of progressive disease) in patients who achieve at least a partial response to treatment.
  • Determine the biomarker response of CA19-9.

OUTLINE: This is an open-label study.

  • Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy (by choice); patients with unresectable disease proceed to chemoradiotherapy.

  • Surgery: Patients undergo surgical resection with the Whipple procedure.
  • Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Biological: cetuximab
  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: conventional surgery
  • Radiation: radiation therapy
  • Drug: Gemcitabine
Study Arms  ICMJE Experimental: Gemcitabine,Oxaliplatin and Cetuximab

Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.

After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.

Interventions:
  • Biological: cetuximab
  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: conventional surgery
  • Radiation: radiation therapy
  • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2018)
39
Original Enrollment  ICMJE
 (submitted: December 6, 2006)
42
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria:

    • Locally advanced, nonmetastatic disease
    • Surgically unresectable disease
  • Measurable disease, defined as unidimensionally measurable by physical exam or imaging study

    • The following are considered nonmeasurable disease:

      • Bone-only disease
      • Pleural or peritoneal effusions
      • CNS lesions
      • Irradiated lesions in the absence of progression after radiotherapy
  • No history or evidence of CNS disease
  • No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy
  • No acute hepatitis
  • No known HIV positivity
  • No active or uncontrolled infection
  • No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Uncontrolled congestive heart failure
    • Cardiomyopathy with decreased ejection fraction
  • No prior severe infusion reaction to a monoclonal antibody
  • No active second malignancy other than nonmelanoma skin cancer
  • No history of deep vein thrombosis
  • No history of bleeding diathesis or coagulopathy
  • No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • No prior therapy for pancreatic cancer
  • No prior therapy specifically targeting the epidermal growth factor-receptor pathway
  • No major surgical procedure or open biopsy within the past 28 days
  • No prior radiotherapy or chemotherapy
  • No prior or concurrent full-dose anticoagulants or thrombolytics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00408564
Other Study ID Numbers  ICMJE CDR0000518313
MUSC-100918
BMS-MUSC-100918
SANOFI-MUSC-100918
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
PRS Account Medical University of South Carolina
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP