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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
capecitabine
gemcitabine hydrochloride
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute
  • Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Progression-free Survival
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.

Secondary Outcome Measures

Percentage of Participants With Grades 3-5 Treatment Related Toxicities
Grade 3, 4 or 5 toxicity rate
Percentage of Participants With Improved Quality of Life
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.
Clinical Response
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.
Overall Survival

Full Information

First Posted
January 6, 2005
Last Updated
November 19, 2015
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00100815
Brief Title
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Official Title
Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Description
30-90 minutes on day 1, every 21 days up to 12 months.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
every 2-4 months for 1 year and then every 6 months for 5 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Grades 3-5 Treatment Related Toxicities
Description
Grade 3, 4 or 5 toxicity rate
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
Title
Percentage of Participants With Improved Quality of Life
Description
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.
Time Frame
assessed at baseline then weekly for 3 weeks
Title
Clinical Response
Description
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.
Time Frame
Pre-treatment and every 6 weeks from treatment.
Title
Overall Survival
Time Frame
every 2-4 months for 1 year and then every 6 months for 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renuka Iyer, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1714
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19491904
Citation
Javle M, Yu J, Garrett C, Pande A, Kuvshinoff B, Litwin A, Phelan J 3rd, Gibbs J, Iyer R. Bevacizumab combined with gemcitabine and capecitabine for advanced pancreatic cancer: a phase II study. Br J Cancer. 2009 Jun 16;100(12):1842-5. doi: 10.1038/sj.bjc.6605099. Epub 2009 Jun 2.
Results Reference
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Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

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