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Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

Primary Purpose

Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bevacizumab
gemcitabine hydrochloride
adjuvant therapy
anti-cytokine therapy
antiangiogenesis therapy
antibody therapy
biological therapy
chemotherapy
conventional surgery
growth factor antagonist therapy
monoclonal antibody therapy
surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas No evidence of distant metastasis on laparoscopy No superior mesenteric artery or thrombosed superior mesenteric vein involvement Superior mesenteric vein or portal vein involvement allowed Evidence of a pancreatic mass by radiographic or endoscopic examination PATIENT CHARACTERISTICS: Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 2,500/mm^3 Absolute neutrophil count ≥ 1,250/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Hepatitis B surface antigen negative Hepatitis C virus negative No history of hepatic cirrhosis Renal Creatinine ≤ 2.0 mg/dL Proteinuria negative or trace by urinalysis OR Protein < 1 g on 24 hr urine collection No active gross hematuria Cardiovascular No severe congestive heart failure No active ischemic heart disease No ischemic changes on a cardiac thallium stress test No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy) No active coagulation disorder Pulmonary No active gross hemoptysis Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during the adjuvant therapy part of trial HIV negative No active infection No wound healing problem from recent invasive procedure No significant history of medical illness that would preclude patient from undergoing an operative procedure No other malignancy requiring systemic therapy PRIOR CONCURRENT THERAPY: Biologic therapy Recovered from prior immunotherapy for pancreatic cancer No prior bevacizumab Chemotherapy Recovered from prior chemotherapy for pancreatic cancer No prior gemcitabine hydrochloride Endocrine therapy Recovered from prior hormonal therapy for pancreatic cancer Radiotherapy Recovered from prior radiotherapy for pancreatic cancer No prior radiotherapy to the pancreas Surgery No prior definitive resection of the primary pancreatic tumor Prior surgery, other than resection of the primary tumor, allowed Other More than 3 weeks since prior systemic therapy for this cancer No concurrent therapeutic anticoagulation causing elevated PT or PTT

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2005
    Last Updated
    April 27, 2015
    Sponsor
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00253526
    Brief Title
    Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer
    Official Title
    Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2006
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
    Detailed Description
    OBJECTIVES: Primary Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab. Secondary Compare overall survival in patients treated with these regimens. Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens. OUTLINE: This is a randomized, controlled study. All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤ 33% vs > 33%). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    bevacizumab
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride
    Intervention Type
    Procedure
    Intervention Name(s)
    adjuvant therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    anti-cytokine therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    antiangiogenesis therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    antibody therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    biological therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    chemotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    growth factor antagonist therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    monoclonal antibody therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas No evidence of distant metastasis on laparoscopy No superior mesenteric artery or thrombosed superior mesenteric vein involvement Superior mesenteric vein or portal vein involvement allowed Evidence of a pancreatic mass by radiographic or endoscopic examination PATIENT CHARACTERISTICS: Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 2,500/mm^3 Absolute neutrophil count ≥ 1,250/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Hepatitis B surface antigen negative Hepatitis C virus negative No history of hepatic cirrhosis Renal Creatinine ≤ 2.0 mg/dL Proteinuria negative or trace by urinalysis OR Protein < 1 g on 24 hr urine collection No active gross hematuria Cardiovascular No severe congestive heart failure No active ischemic heart disease No ischemic changes on a cardiac thallium stress test No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy) No active coagulation disorder Pulmonary No active gross hemoptysis Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during the adjuvant therapy part of trial HIV negative No active infection No wound healing problem from recent invasive procedure No significant history of medical illness that would preclude patient from undergoing an operative procedure No other malignancy requiring systemic therapy PRIOR CONCURRENT THERAPY: Biologic therapy Recovered from prior immunotherapy for pancreatic cancer No prior bevacizumab Chemotherapy Recovered from prior chemotherapy for pancreatic cancer No prior gemcitabine hydrochloride Endocrine therapy Recovered from prior hormonal therapy for pancreatic cancer Radiotherapy Recovered from prior radiotherapy for pancreatic cancer No prior radiotherapy to the pancreas Surgery No prior definitive resection of the primary pancreatic tumor Prior surgery, other than resection of the primary tumor, allowed Other More than 3 weeks since prior systemic therapy for this cancer No concurrent therapeutic anticoagulation causing elevated PT or PTT
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard E. Royal, MD, FACS
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

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