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Pancreatic CancerPhase 1/2NCT00307723

Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer

A Phase 1/2 study testing bevacizumab, 5-Fluorouracil and Oxaliplatin in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Massachusetts General Hospital.

Terminated

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

Official record
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Trial summary

The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab, 5-Fluorouracil and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
May 2006to Jul 2009
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

Who may be able to join

  • Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy
  • Disease is measurable by CT scan
  • Age >= to 18 years
  • Life expectancy of 4 months or longer
  • ANC >/= 1,500mm/cm3
  • Hemoglobin >/= 9g/dl
Show all 11Show fewer
  • Platelet count >/= 100,000/cm3
  • Total bilirubin </= 2 times control
  • SGOT/SGPT </= 2.5 times upper limit of normal
  • Serum creatinine < 2mg/dl
  • No evidence of metastatic disease by laparoscopy

Who cannot join

  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications
  • No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years
  • Patients with pre-existing peripheral neuropathy of grade 2 or greater
  • Pregnant or lactating women
  • Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study
  • Blood pressure of >150/100 mmHg
Show all 17Show fewer
  • Unstable angina
  • New York Heart Association Grade II or greater congestive heart failure
  • History of myocardial infarction or stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of central nervous system or brain metastases
  • Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
  • Urine protein creatinine ratio > or = to 1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
  • Serious, non-healing wound, ulcer, or bone fracture

About this study

Official title: A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer

The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).

Read the detailed description
  • The combination of all three drugs and radiation treatment has never been given to people before, therefore, we are going to add just one additional drug at a time for safety reasons.
  • The first group of participants (3-4) who enroll on the study will receive 5-FU, radiation therapy with the added drug oxaliplatin, this is called Regimen level 1. If these participants have few or easily manageable side effects, then another group of participants will be enrolled and will receive 5-FU, radiation, oxaliplatin with the addition of bevacizumab this is called Regimen level 2.
  • The combination of study drugs and radiation will last about 6 weeks, this 6 week period is called a cycle 1.
  • Regimen Level 1 will receive the following: oxaliplatin intravenously on days 1, 8, 15, 22, 29, and 36; 5-FU infused by a continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day 38.
  • Regimen Level 2 will receive the following; bevacizumab intravenously on days 1, 15, and 29; oxaliplatin intravenously on days 1, 8, 15, 22, 29 and 36; 5-FU infused by continuous infusion days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day day 38.
  • The following are tests and procedures that will be performed during cycle 1: physical examination; blood work, urine sample. perfusion CT scan on day 12 (for those participants enrolled at Massachusetts General Hospital).
  • At the end of cycle 1, CT scans will be performed to evaluate the participants disease status before they receive combination gemcitabine and bevacizumab. If the scans show the tumor has reduced in size and can be surgically removed, then surgery will be scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after the surgery. If the scans show the tumor can not be removed, the patient will receive the gemcitabine/bevacizumab combination about 4 weeks after completing cycle 1.
  • Cycles 2-5 consist of: gemcitabine given intravenously on days 1, 8, and 15 every 28 days; bevacizumab given intravenously on days 1 and 15 every 28 days. During cycles 2-5 the following tests and procedures will be performed: physical examination including vital signs on day 1 and 15 of each cycle; blood work on days 1, 8 and 15 of each cycle; a urine sample on day 1 of each cycle; CT scans will be done every 2 cycles.
  • It will take about 7 months to complete the study treatment (longer for those who have surgery after Cycle 1).
Being tested
bevacizumab, 5-Fluorouracil, Oxaliplatin, gemcitabine, External Beam Radiation Therapy
Keywords
EBRT, advanced 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.

  • bevacizumabDrug

    Intravenously on days 1, 15 and 29 of the first cycle. Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.

  • 5-FluorouracilDrug

    Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.

  • OxaliplatinDrug

    Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.

  • gemcitabineDrug

    Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.

  • External Beam Radiation TherapyProcedure or surgery

    Monday through Friday ending on day 38 of cycle 1

Study groups in NCT00307723
Study groupRoleWhat they receive
Regimen Level 1ExperimentalRadiation/Oxaliplatin/5-FU
Receives: Drug: bevacizumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: gemcitabine; Procedure: External Beam Radiation Therapy
Regimen Level 2ExperimentalRadiation/Oxaliplatin/Bevacizumab/5-FU
Receives: Drug: bevacizumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: gemcitabine; Procedure: External Beam Radiation Therapy

What is being measured

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

  1. To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer

    Measured: 2 years

  2. to determine the survival of patients treated with this regimen.

Secondary outcomes (4)

  1. To determine the progression free survival

  2. to determine the rate of conversion to resectability after treatment

    Measured: 2 years

  3. to asses the duration of response and response rate of this combination and

  4. to evaluate the toxicities.

    Measured: 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 posted28 Mar 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2007
  4. Study completionJul 2009

Why it stopped: poor 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307723
Sponsor's protocol ID
05-233
Status last verified
Aug 2009
First submitted
24 Mar 2006
Last updated
10 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bevacizumab, 5-Fluorouracil and Oxaliplatin in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Massachusetts General Hospital.

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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 10 Aug 2009. 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.

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: poor accrual). 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?

To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer (time frame: 2 years). 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 NCT00307723.

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 10 Aug 2009.

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