Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

November 19, 2015 updated by: Roswell Park Cancer Institute

Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.

Secondary

  • Determine clinical response in patients treated with this regimen.
  • Determine toxicity of this regimen in these patients.
  • Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline then weekly for 3 weeks.

Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5 months.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106-1714
        • Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following criteria:

    • Newly diagnosed or previously treated metastatic disease
    • Unresectable disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • WBC > 3,000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin < 2 mg/dL
  • AST or ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • INR < 1.5 (except for patients receiving full-dose warfarin)

Renal

  • Creatinine < 1.5 mg/dL
  • No proteinuria OR
  • Urine protein < 500 mg by 24-hour urine collection
  • No clinically significant impairment of renal function

Cardiovascular

  • No uncontrolled hypertension (blood pressure > 160/110 mm Hg on medication)
  • No New York Heart Association class II-IV congestive heart failure

  • No unstable symptomatic arrhythmia requiring medication

    • Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
  • No clinically significant grade II-IV peripheral vascular disease

  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious systemic disease
  • No significant traumatic injury within the past 28 days
  • No serious non-healing wound, ulcer, or bone fracture
  • No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior fine needle aspirations or core biopsies
  • No concurrent major surgery

Other

  • More than 4 weeks since prior and no concurrent participation in any other experimental drug study
  • More than 12 months since prior adjuvant therapy
  • No prior systemic therapy for metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: every 2-4 months for 1 year and then every 6 months for 5 years
Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
every 2-4 months for 1 year and then every 6 months for 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Grades 3-5 Treatment Related Toxicities
Time Frame: Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years
Grade 3, 4 or 5 toxicity rate
Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years
Percentage of Participants With Improved Quality of Life
Time Frame: assessed at baseline then weekly for 3 weeks
Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.
assessed at baseline then weekly for 3 weeks
Clinical Response
Time Frame: Pre-treatment and every 6 weeks from treatment.
Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.
Pre-treatment and every 6 weeks from treatment.
Overall Survival
Time Frame: every 2-4 months for 1 year and then every 6 months for 5 years
every 2-4 months for 1 year and then every 6 months for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Renuka Iyer, MD, Roswell Park Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 6, 2005

First Submitted That Met QC Criteria

January 6, 2005

First Posted (Estimate)

January 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000409556
  • RPCI-I-19903
  • GENENTECH-RPCI-I-19903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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