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Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Pancreas

Primary Purpose

Pancreatic Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cetuximab
gemcitabine hydrochloride
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas that is not amenable to curative surgical resection Immunohistochemical evidence of EGFr expression of 1+ or greater Measurable disease No history of treated or active brain metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 No unstable coagulation disorders Hepatic: AST/ALT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled hypertension or arrhythmias No unstable congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent unstable medical condition (e.g., uncontrolled diabetes mellitus or active infections requiring systemic antibiotics, antivirals, or antifungals) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab Chemotherapy: No prior chemotherapy for advanced pancreatic cancer Prior adjuvant chemotherapy following complete surgical resection allowed provided cancer recurrence was first documented more than 6 months after completion of treatment Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless documented disease progression since prior irradiation Surgery: Prior surgical resection allowed Other: At least 4 weeks since other prior investigational agents

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2000
    Last Updated
    December 11, 2013
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005591
    Brief Title
    Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Pancreas
    Official Title
    Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    October 1999 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.
    Detailed Description
    OBJECTIVES: I. Determine objective response, time to progression, survival, clinical benefit response, and quality of life of patients with locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas when treated with cetuximab and gemcitabine. II. Determine the safety and toxicity profile of this regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive a test dose of cetuximab IV over 10 minutes followed by a 30 minute observation period. Following observation, patients receive a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over 30 minutes weekly for 7 weeks. Following 1 week of rest, patients with stable or responding disease continue treatment for a maximum of 6 months. During subsequent courses, patients receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks. Gemcitabine IV is administered over 30 minutes weekly for 3 weeks, followed by 1 week of rest, and then repeated for a total treatment course of 8 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after each course of therapy, and at 3 months after therapy. Patients are followed every 3 months until evidence of disease progression. PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study within 8 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    cetuximab
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas that is not amenable to curative surgical resection Immunohistochemical evidence of EGFr expression of 1+ or greater Measurable disease No history of treated or active brain metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 No unstable coagulation disorders Hepatic: AST/ALT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled hypertension or arrhythmias No unstable congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent unstable medical condition (e.g., uncontrolled diabetes mellitus or active infections requiring systemic antibiotics, antivirals, or antifungals) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab Chemotherapy: No prior chemotherapy for advanced pancreatic cancer Prior adjuvant chemotherapy following complete surgical resection allowed provided cancer recurrence was first documented more than 6 months after completion of treatment Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless documented disease progression since prior irradiation Surgery: Prior surgical resection allowed Other: At least 4 weeks since other prior investigational agents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Albert F. LoBuglio, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Pancreas

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