NCT00114179

Brief Summary

Drugs used in chemotherapy, such as capecitabine and gemcitabine, 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 and 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may kill more tumor cells. This phase II trial is studying how well giving capecitabine and bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

June 13, 2005

Last Update Submit

October 29, 2020

Conditions

Adenocarcinoma of the PancreasStage II Pancreatic CancerStage III Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    Will be estimated using the Kaplan-Meier method.

    1 year

Secondary Outcomes (3)

  • Frequency of patients developing grade 3 or greater adverse events as defined per CTCAE version 3.0

    Up to 1 year

  • Progression-free survival

    Up to 1 year

  • Response rate

    Up to 1 year

Study Arms (1)

Treatment (capecitabine, radiation, bevacizumab, gemcitabine)

EXPERIMENTAL

Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab. Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later. Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: capecitabineRadiation: radiation therapyBiological: bevacizumabProcedure: therapeutic conventional surgeryDrug: gemcitabine hydrochloride

Interventions

capecitabineDRUG

Given orally

Also known as: CAPE, Ro 09-1978/000, Xeloda
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
radiation therapyRADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the pancreas
  • Locally advanced disease
  • Unresectable disease
  • All malignant disease must be encompassable within a single irradiation field
  • Radiographically assessable disease
  • Patients with biliary or gastroduodenal obstruction are eligible provided drainage or surgical bypass was performed prior to initiation of study treatment
  • No evidence of gastric outlet obstruction
  • No evidence of duodenal invasion on CT scan
  • No evidence of metastatic disease in the major viscera
  • No peritoneal seeding or ascites
  • Performance status - Zubrod 0-1
  • Granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No evidence of bleeding diathesis
  • ALT \< 3 times upper limit of normal
  • +51 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • Crane CH, Winter K, Regine WF, Safran H, Rich TA, Curran W, Wolff RA, Willett CG. Phase II study of bevacizumab with concurrent capecitabine and radiation followed by maintenance gemcitabine and bevacizumab for locally advanced pancreatic cancer: Radiation Therapy Oncology Group RTOG 0411. J Clin Oncol. 2009 Sep 1;27(25):4096-102. doi: 10.1200/JCO.2009.21.8529. Epub 2009 Jul 27.

    PMID: 19636002DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CapecitabineRadiotherapyRadiationBevacizumabGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTherapeuticsPhysical PhenomenaAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Christopher Crane

    Radiation Therapy Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

US(1)