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Adenocarcinoma of the PancreasPhase 2NCT00114179

Capecitabine, Bevacizumab, and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

A Phase 2 study testing capecitabine, radiation therapy and bevacizumab in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
capecitabine, radiation therapy and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
Jan 2005to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 66Show fewer
  • 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
  • Bilirubin < 2.0 mg/dL
  • INR ≤ 1.5
  • No evidence of coagulopathy
  • Creatinine clearance > 50 mL/min
  • Urine protein < 1,000 mg by 24-hour urine collection (for patients with proteinuria ≥ 1+ by dipstick or urinalysis OR urine protein:creatinine ratio ≥ 1.0)
  • No myocardial infarction within the past 6 months
  • No unstable angina within the past 6 months
  • No arterial thromboembolic events within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Clinically significant peripheral artery disease
  • No unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [i.e., atrial fibrillation or paroxysmal supraventricular tachycardia])
  • Patients with an atrial arrhythmia are eligible provided the condition is well controlled on stable medication
  • No New York Heart Association class II-IV congestive heart failure
  • No history of arteriovenous malformation
  • No history of aneurysm
  • No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg with medication)
  • No other clinically significant cardiac disease
  • No AIDS
  • No significant infection
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Not pregnant
  • No nursing during and for ≥ 3-4 months after completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3-4 months after completion of study treatment
  • No history of gastrointestinal fistula or perforation
  • No other malignancy within the past two years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
  • No significant traumatic injury within the past 4 weeks
  • No serious nonhealing wound or ulcer
  • No current healing fracture
  • No known or suspected dihydropyrimidine dehydrogenase deficiency
  • No other medical condition that would preclude study participation
  • No concurrent interleukin-11
  • No prior chemotherapy for pancreatic cancer
  • More than 2 years since prior chemotherapy for another malignancy
  • No prior radiotherapy to the planned irradiation field
  • No concurrent intensity modulated radiotherapy
  • No other concurrent radiotherapy
  • See Disease Characteristics
  • More than 4 weeks since prior major surgical procedure or open biopsy
  • More than 1 week since prior fine needle aspiration or core biopsy
  • No prior organ transplantation
  • No concurrent major surgical procedure
  • More than 30 days since prior and no concurrent cimetidine
  • Concurrent ranitidine or a drug from another anti-ulcer class allowed
  • More than 4 weeks since prior and no concurrent sorivudine or brivudine
  • No concurrent warfarin during chemoradiotherapy
  • Concurrent warfarin allowed beginning 2 weeks after completion of chemoradiotherapy
  • Concurrent low molecular weight heparin allowed (at any time during study participation)
  • No other concurrent investigational agents
  • No other concurrent cytotoxic agents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine, bevacizumab, and radiotherapy followed by maintenance therapy comprising gemcitabine and bevacizumab to a historical control.

SECONDARY OBJECTIVES:

  1. Determine the frequency of serious unacceptable adverse events in patients treated with this regimen.

II. Determine the response rate in patients treated with this regimen. III. Determine the progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

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.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study within 16 months.

Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    Also called CAPE, Ro 09-1978/000, Xeloda

    Given orally

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiotherapy

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • therapeutic conventional surgeryProcedure or surgery

    Undergo surgery

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

Study groups in NCT00114179
Study groupRoleWhat they receive
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)ExperimentalChemoradiotherapy 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.
Receives: Drug: capecitabine; Radiation: radiation therapy; Biological: bevacizumab; Procedure: therapeutic conventional surgery; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival rate

    Will be estimated using the Kaplan-Meier method.

    Measured: 1 year

Secondary outcomes (3)

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

    Measured: Up to 1 year

  2. Progression-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  3. Response rate

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionMay 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114179
Sponsor's protocol ID
NCI-2012-02661
Other IDs
NCI-2012-02661, CDR0000434846, RTOG-0411, RTOG-0411, U10CA021661
Status last verified
Oct 2020
First submitted
13 Jun 2005
Last updated
30 Oct 2020
Results posted
No

Publications

  • 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.

    PubMed 19636002

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, radiation therapy and bevacizumab in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 66 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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