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Pancreatic CancerNCT00524069

Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

A study testing bevacizumab, capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Roswell Park Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. 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
Conditions the study is for
Pancreatic Cancer
What is being tested?
bevacizumab, capecitabine and gemcitabine hydrochloride
Type of treatment
Surgery or procedure
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2007to Nov 2007
Phase
Interventional
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Resectable disease (i.e., stage I or II disease)
  • No unresectable (i.e., locally advanced) disease
  • No tumor invasion into the stomach or duodenum
  • No CNS, brain, or systemic metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,000/μL
  • ANC > 1,500/μL
  • Platelet count > 100,000/μL
  • Total bilirubin < 2 mg/dL
  • AST or ALT < 2.5 times upper limit of normal (ULN)
  • Creatinine < 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio < 1.0
  • Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)
  • INR < 1.5 times ULN (except in patients receiving full-dose warfarin)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled hypertension
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No esophageal or gastric varices
  • No serious nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

  • No prior therapy for pancreatic cancer
  • More than 4 weeks since prior and no concurrent participation in another experimental drug study
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)

About this study

Official title: A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma

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. 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 tumor cells by blocking blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with pancreatic cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the feasibility and safety of bevacizumab-based neoadjuvant and adjuvant therapy in patients with resectable pancreatic adenocarcinoma.
  • To determine the proportion of patients with margin-positive resections after pancreatic resection.

Secondary

  • To estimate overall survival of patients treated with this regimen.
  • To assess the time to recurrence in patients treated with this regimen.
  • To measure the change in the number of circulating endothelial precursor cells (CEC) and VEGF expression on CEC at baseline and after the start of neoadjuvant therapy and examine their relationship with response, time to recurrence, and survival.
  • To assess the utility of dynamic contrast-enhanced spiral CT scan as surrogate endpoints for antiangiogenic therapy.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy: Patients receive gemcitabine IV over 30 minutes on days 1 and 8; oral capecitabine twice daily on days 1-14; and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients receive bevacizumab during courses 1 and 2 only.

  • Surgical resection: Within 6-8 weeks after the last dose of bevacizumab, patients undergo surgical resection of the pancreatic tumor.
  • Adjuvant therapy: Beginning 6-10 weeks after surgery, patients receive up to 6 additional courses of gemcitabine, capecitabine, and bevacizumab as in neoadjuvant therapy.

Patients undergo blood sample collection at baseline and periodically during study for biomarker correlative studies. Samples are analyzed by flow cytometry to measure levels of circulating endothelial precursor cells and VEGF markers of angiogenesis. Patients also undergo dynamic contrast-enhanced (DCE) spiral CT scan of the abdomen. DCE-CT imaging studies are performed at baseline and after completion of neoadjuvant therapy (1-2 weeks prior to surgical resection) to assess changes in tumor blood flow, blood volume, and tumor vasculature.

After completion of study therapy, patients are followed periodically for at least 5 years.

Being tested
bevacizumab, capecitabine, gemcitabine hydrochloride, flow cytometry, laboratory biomarker analysis
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

What is being measured

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

  1. Feasibility and safety

  2. Margin status after pancreatic resection

Secondary outcomes (8)

  1. Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins

  2. Median survival

  3. Time to recurrence

  4. Overall survival

  5. Number of circulating endothelial precursor cells (CEC) and their VEGFR expression as measured by flow cytometry at baseline and after the start of neoadjuvant therapy

  6. Correlation of CEC number and VEGFR expression with margin positivity, survival, and recurrence

  7. Changes in blood volume, blood flow, mean transit time, and color flow maps of the tumor as measured by dynamic contrast-enhanced spiral CT scan at baseline and after completion of neoadjuvant therapy

  8. Toxicity

Timeline

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

  1. First posted3 Sep 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionNov 2007

Why it stopped: Withdrawn due to no accrual

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 N/A
Primary purpose
Treatment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524069
Sponsor's protocol ID
I 68805
Other IDs
RPCI-I-68805
Status last verified
Jan 2013
First submitted
31 Aug 2007
Last updated
1 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab, capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Roswell Park Cancer Institute.

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

Who may be eligible to take part?

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: withdrawn, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Feasibility and safety. The study lists 2 primary outcomes in all. 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 NCT00524069.

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 1 Feb 2013.

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