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AzTrials

Pancreatic CancerPhase 2NCT00609765

Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

A Phase 2 study testing Avastin, Fluorouracil and Doxorubicin in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Avastin, Fluorouracil and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Aug 2007to Mar 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have locally advanced (unresectable) or metastatic, well or moderately differentiated pancreatic endocrine tumors.
  • Measurable disease on CT scan or MRI.
  • Age ≥ 18 years and ≤ 80 years.
  • Use of effective means of contraception (men and women) in subjects of child-bearing potential
  • Adequate renal function (serum creatinine ≤1.5, urine protein:creatinine ratio <1.0 or urine dipstick for proteinuria < 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours to be eligible).
  • Adequate hepatic function (bilirubin ≤2.0, AST and ALT ≤ 3x ULN.
  • Adequate hematologic function (WBC ≥ 3,000, ANC ≥ 1500, platelets ≥ 100,000)

Who cannot join

  • Prior therapy with fluorouracil, doxorubicin, streptozocin or avastin
  • Ejection fraction on MUGA <50%
  • ECOG performance status > 2
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored avastin cancer study
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
Show all 25Show fewer
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of central nervous system or brain metastases
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential
  • Proteinuria at screening as demonstrated by either
  • Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening OR
  • Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Evidence of duodenal invasion on CT scan, MRI, or endoscopy
  • Known hypersensitivity to any component of avastin
  • Serious, non-healing wound, ulcer, or bone fracture
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.

Read the detailed description

Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor

  • Will do a physical exam
  • Will take blood for routine lab tests
  • Will do a urinalysis
  • Will administer study medication Some study visits may be longer because patient will have a CT scan or an MRI.

At patient's last visit, they will have a CT scan or MRI.

After treatment starts, patient will:

  • Have their blood pressure monitored with every dose of Avastin® (about every 2 weeks).
  • Have a history and physical with every chemotherapy cycle (about every 4 weeks).
  • Have their blood taken for routine blood tests with every chemotherapy cycle (about every 4 weeks).
  • Have a CT scan or MRI during every other cycle (about every 8 weeks).
  • Have a MUGA scan during every 4 cycles (about 16 weeks).
  • Have blood taken for tumor markers during every cycle only if their markers were high at baseline.
  • Patients will receive study medication to treat their cancer:
  • Fluorouracil on days 1 through 5 of each cycle through cycle 12
  • Doxorubicin on day 1 of each cycle through cycle 8
  • Streptozocin on days 1 through 5 of each cycle through cycle 12
  • Avastin® on days 1 and 15 of each cycle through cycle 12
Being tested
Avastin, Fluorouracil, Doxorubicin, Streptozocin, Dexamethasone
Keywords
advanced, unresectable, metastatic, endocrine, tumors
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

  • AvastinDrug

    Also called bevacizumab

    Every 28 Days: Avastin 5mg/kg iv days 1 and 15

  • FluorouracilDrug

    Also called Fluoroplex, 5-FU, Efudex

    Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5

  • DoxorubicinDrug

    Also called Adriamycin®

    Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1

  • StreptozocinDrug

    Also called Zanosar®

    Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5

  • DexamethasoneDrug

    Also called Decadron

    Premedication: Dexamethasone 20mg intravenously days 1-5

  • OndansetronDrug

    Also called Zofran

    Premedication: Ondansetron 16mg intravenously days 1-5

Study groups in NCT00609765
Study groupRoleWhat they receive
Protocol Specified ChemotherapyExperimentalProtocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin. Premedications: Dexamethasone, Ondansetron
Receives: Drug: Avastin; Drug: Fluorouracil; Drug: Doxorubicin; Drug: Streptozocin; Drug: Dexamethasone; Drug: Ondansetron

What is being measured

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

  1. Number of Participants With Progression Free Survival (PFS) at 12 Months

    We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).

    Measured: 12 months

Secondary outcomes (1)

  1. The Number of Participants With Radiographic Response

    Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.

    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 posted7 Feb 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionMar 2008
  4. Study completionMar 2008

Why it stopped: Development of new chemotherapy standard of care for treatment rendered the trial obsolete.

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609765
Sponsor's protocol ID
MCC-14961
Other IDs
AVF3915s
Status last verified
Mar 2011
First submitted
24 Jan 2008
Last updated
23 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin, Fluorouracil and Doxorubicin in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 inclusion and 25 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 23 Mar 2017. 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?

Yes. Results are posted in the registry (first posted 22 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Progression Free Survival (PFS) at 12 Months (time frame: 12 months). 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 NCT00609765.

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 23 Mar 2017.

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