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Pancreatic CancerPhase 1/2NCT00410774

Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery

A Phase 1/2 study testing bevacizumab, gemcitabine hydrochloride and adjuvant therapy in people with Pancreatic Cancer, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as 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
Conditions the study is for
Pancreatic Cancer
What is being tested?
bevacizumab, gemcitabine hydrochloride and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2006to Oct 2007
Phase
Phase 1/2
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Completely resected disease
  • Underwent 1 of the following procedures 3-8 weeks ago:
  • Standard pancreaticoduodenectomy (for tumors of the pancreatic head)
  • Distal pancreatectomy (for tumors of the pancreatic tail)
  • No grossly positive surgical margins
  • Positive microscopic margins allowed
  • Nonmeasurable disease
  • No known CNS disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • CA 19-9 ≤ 2.5 times upper limit of normal (ULN)
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
  • Platelet count ≥ 100,000/mm³
  • INR ≤ 1.5 (except in patients receiving full-dose warfarin)
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • No clinically significant impairment of renal function
  • No postoperative complications, including any of the following:
  • Wound dehiscence or infection
  • Intra-abdominal abscess
  • Pancreatic or biliary leak or fistula
  • Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)
  • Bowel perforation
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months
  • No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications
  • No other cancer within the past 5 years except basal cell or squamous cell skin cancer
  • No history of serious systemic disease, including any of the following:
  • Myocardial infarction or unstable angina within the past 12 months
  • New York Heart Association class II-IV congestive heart failure
  • Unstable symptomatic arrhythmia requiring medication
  • Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
  • No history of stroke or transient ischemic attack
  • No symptomatic peripheral vascular disease
  • No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on antihypertensive medication)
  • No prior hypertensive crisis or hypertensive encephalopathy
  • No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)
  • No serious, nonhealing wound or ulcer
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for pancreatic cancer
  • No prior systemic or investigational therapy for pancreatic cancer
  • No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days
  • No fine-needle aspiration or core biopsy within the past 7 days
  • No anticipated need for a major surgical procedure during study treatment
  • No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Concurrent chronic-dose NSAIDs for analgesia are allowed

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as 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. Giving gemcitabine and bevacizumab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and bevacizumab in patients with completely resected pancreatic cancer.
  • Determine the 1-year disease-free survival rate in patients treated with this regimen.

Secondary

  • Determine the 1- and 2-year overall survival rates in these patients.
  • Determine the median disease-free survival rate in these patients.
  • Determine the median overall survival rate in these patients.

OUTLINE: This is an open-label, non-randomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity.

NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed since surgery.

After completion of study therapy, patients are followed periodically for 18 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Keywords
stage III pancreatic cancer, stage I pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer
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. Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0

  2. Disease-free survival rate at 1 year

Secondary outcomes (3)
  1. Overall survival rate at 1 and 2 years

  2. Median disease-free survival rate at 1 and 2 years

  3. Median overall survival rate at 1 and 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 posted13 Dec 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

Why it stopped: low accrual-no data available

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410774
Sponsor's protocol ID
CDR0000517330
Other IDs
UCSF-06451, UCSF-H12191-28980-01
Status last verified
Sep 2012
First submitted
11 Dec 2006
Last updated
17 Sep 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bevacizumab, gemcitabine hydrochloride and adjuvant therapy in people with Pancreatic Cancer, run by University of California, San Francisco 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?

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: stopped early, as of the sponsor's last update on 17 Sep 2012. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: low accrual-no data available). Results are not available in the source record.

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?

Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0. 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?
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 17 Sep 2012.

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