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Adenocarcinoma of the PancreasPhase 2NCT00028834

Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer

A Phase 2 study testing gemcitabine hydrochloride, bevacizumab and laboratory biomarker analysis in people with Adenocarcinoma of the Pancreas and Recurrent 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

This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, bevacizumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Feb 2002to Dec 2004
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 or cytologically confirmed pancreatic adenocarcinoma
  • Not amenable to curative treatment with surgery or radiotherapy
  • Locally advanced disease must extend outside the boundaries of a standard radiation port
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Pleural effusions and ascites not considered measurable lesions
Show all 56Show fewer
  • No obvious tumor involvement of major vessels on CT scan
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No prior bleeding diathesis
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal
  • PT INR no greater than 1.5
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • Urine protein less than 500 mg/24 hours if at least 1+ proteinuria
  • No significant renal impairment
  • No prior cardiovascular accident
  • No prior deep vein thrombosis
  • No myocardial ischemia or infarction within the past 6 months
  • No uncompensated coronary artery disease within the past 6 months
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No cardiac arrhythmia
  • No clinically significant peripheral artery disease
  • No arterial thromboembolic event within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • No prior pulmonary embolism
  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No other concurrent active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No psychiatric illness or social situation that would preclude study entry
  • No prior allergic reaction attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents (Chinese hamster ovary cell products or other recombinant human antibodies) used in this study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior bevacizumab
  • No prior cytotoxic chemotherapy for metastatic disease
  • No prior gemcitabine
  • At least 4 weeks since prior adjuvant chemotherapy and recovered
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to sole site of measurable disease
  • At least 6 weeks since prior major surgery
  • At least 30 days since prior investigational agents
  • At least 1 month since prior and no concurrent thrombolytic agents or full-dose anticoagulants (except to maintain patency of pre-existing permanent indwelling IV catheters)
  • No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer

This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the objective response rate of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.

II. To determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.

III. To determine median and overall survival of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.

SECONDARY OBJECTIVES:

  1. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a predictor of outcome.

II. To collect and store serum samples for possible future assessment of other antiangiogenic inhibition markers.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Being tested
gemcitabine hydrochloride, bevacizumab, laboratory biomarker analysis
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • bevacizumabBiological

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

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00028834
Study groupRoleWhat they receive
Treatment (gemcitabine hydrochloride, bevacizumab)ExperimentalPatients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: gemcitabine hydrochloride; Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective response rate (complete or partial responses)

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Progression-free survival

    Calculated using the Kaplan-Meier method, and the median progression-free survival times and the associated 95% confidence intervals derived.

    Measured: Up to 2 years

  2. Overall survival

    Calculated using the Kaplan-Meier method, and the median overall survival times and the associated 95% confidence intervals derived.

    Measured: Up to 2 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionDec 2004

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028834
Sponsor's protocol ID
NCI-2012-02440
Other IDs
11255B, N01CM17102, CDR0000069138
Status last verified
Jan 2013
First submitted
4 Jan 2002
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, bevacizumab and laboratory biomarker analysis in people with Adenocarcinoma of the Pancreas and Recurrent 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 56 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 24 Jan 2013. 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?

Objective response rate (complete or partial responses) (time frame: Up to 2 years). 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 NCT00028834.

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 24 Jan 2013.

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