Gemcitabine, Capecitabine, And Bevacizumab In Treating Patients With Metastatic Or Unresectable Pancreatic Cancer

Study Overview

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

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.

Pancreatic Cancer

BIOLOGICAL: bevacizumab
DRUG: capecitabine
DRUG: gemcitabine hydrochloride

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-01-06	Results First Submitted 2015-09-28	Last Update Submitted that met QC Criteria 2015-11-19
First Submitted that Met QC Criteria 2005-01-06	Results First Submitted that Met QC Criteria 2015-11-19	Last Update Posted (ESTIMATED) 2015-12-24
First Posted (ESTIMATED) 2005-01-07	Results First Posted 2015-12-24	Last Verified 2015-11

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
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.	every 2-4 months for 1 year and then every 6 months for 5 years

Secondary Outcome Measures	Measure Description	Time Frame
Percentage of Participants With Grades 3-5 Treatment Related Toxicities	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	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	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		every 2-4 months for 1 year and then every 6 months for 5 years

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Over 18

ECOG 0-1

More than 3 months

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

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)

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

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

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

Not specified

Not specified

Not specified

Not specified

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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Renuka Iyer, MD, Roswell Park Cancer Institute

Publications

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

General Publications

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.

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