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Pancreatic CancerPhase 2NCT01080248

Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

A Phase 2 study testing Gemcitabine and Pazopanib in people with Pancreatic Cancer, run by Washington University School of Medicine 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

To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer. 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?
Gemcitabine and Pazopanib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Aug 2010to Oct 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have a histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  • Patient must have metastatic disease that is not amenable to surgical resection.
  • Patient must have measurable disease (by RECIST criteria), defined as at least one lesion that can be accurately measured in at least one dimension.
  • Patient may have previously untreated disease or may have been previously treated if they meet the following criteria:
  • received adjuvant gemcitabine therapy >6 months prior to enrollment with progression off therapy
  • received prior radiation therapy > 4 weeks prior to study enrollment and have measurable tumor mass outside the radiation field
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  • received prior radiation therapy > 4 weeks prior to study enrollment, have a measurable tumor mass outside the radiation field, and received 5-FU as a radiation sensitizer >4 weeks prior to study enrollment
  • Patient must be >=18 years old. Note: pazopanib is contraindicated in the pediatric population due to the potential effect on the epiphyseal growth plates.
  • Patient must have an ECOG performance status of 0-1
  • Patient must have normal organ and marrow function within 14 days of study initiation as defined below:
  • ANC ≥ 1.5 x 109/L
  • Hemoglobin ≥ 9 g/dL; patients may not have had a transfusion within 7 days of screening assessment
  • Platelets ≥ 100 x 109/L
  • PT or INR ≤ 1.2 x upper limit of normal (ULN)
  • PTT ≤ 1.2 x ULN
  • Total bilirubin ≤ 1.5 x ULN
  • AST and ALT ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 mg/dL; if > 1.5 mg/dL, calculated creatinine clearance must be ≥ 50 mL/min
  • Urine protein to creatinine ratio < 1; if ≥ 1, then a 24-hour urine protein must be assessed and must be < 1 g in order for patients to be eligible
  • Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Who cannot join

  • Patient has been treated with an agent that antagonizes the VEGF receptor.
  • Patient has received any other investigational agents < 28 days prior to enrollment.
  • Patient has known brain metastases; these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. In addition, patients with brain metastases may be at a higher theoretical risk for cerebral hemorrhage while taking pazopanib.
  • Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib, gemcitabine, or other agents used in the study.
  • Patient has an increased risk of hemorrhage such as having received thrombolytic agents within the past month, being on an unstable dose of anticoagulation, or having a known bleeding diathesis.
  • Patient has a clinically significant gastrointestinal abnormality that may increase the risk for GI bleeding such as:
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  • Active inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess ≤ 28 days prior to beginning study treatment
  • Patient has a history of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery by-pass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Patient has prolonged QT intervals, taking antiarrhythmics or taking other medications that prolong QT
  • Patient has poorly controlled hypertension (defined as systolic blood pressure (SBP) of ≥160 mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg). Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.
  • Patient has a history of cerebrovascular accident, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Patient has had major surgery, trauma, non-healing wound, fracture, or ulcer within 28 days prior to first dose of gemcitabine and/or study drug (procedures such as catheter placement not considered to be major) OR minor surgery within 14 days prior to first dose of gemcitabine and/or study drug.
  • Patient has significant proteinuria as evidenced by urine protein/creatinine ratio >1
  • Patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active second malignancy, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient is pregnant or breastfeeding. Pregnant women are excluded from this study because pre-clinical reproductive toxicity studies with pazopanib demonstrated reduced female fertility and teratogenic effects.
  • Patient is known HIV-positive. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Patient is a known alcohol, cocaine, or IV drug abuser within 6 months prior to enrollment.
  • Patient is receiving treatment with any of the following anti-cancer therapies:
  • Radiation therapy, surgery, or tumor embolization within 4 weeks prior to the first dose of pazopanib OR
  • Chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 28 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib.
  • Patient is experiencing any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Study of Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer.

Read the detailed description

To determine the response rate by RECIST criteria.

To determine the progression free survival.

To determine the median survival and overall survival at one year.

Being tested
Gemcitabine, Pazopanib
Keywords
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.

  • GemcitabineDrug

    Also called Gemzar

  • PazopanibDrug

    Also called Votrient

Study groups in NCT01080248
Study groupRoleWhat they receive
Arm 1 (gemcitabine & pazopanib)ExperimentalGemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle. Pazopanib 800 mg PO daily of each 28 day cycle.
Receives: Drug: Gemcitabine; Drug: Pazopanib

What is being measured

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

  1. Response Rate by RECIST Criteria.

    • Response rate = complete response + partial response per RECIST
    • Complete response - disappearance of all target and non-target lesions.
    • Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter

    Measured: Follow-up was approximately 9 weeks

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    • PFS is defined as the duration of time from start of treatment to time to progression.
    • Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Follow-up was approximately 9 weeks

  2. Median Survival

    Measured: Length of follow-up was 35 weeks

  3. Overall Survival

    Measured: 1 year

Timeline

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

  1. First posted4 Mar 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2010
  4. Study completionOct 2011

Why it stopped: Closed due to delay by GSK

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080248
Sponsor's protocol ID
10-0434 / 201103201
Status last verified
May 2015
First submitted
2 Mar 2010
Last updated
9 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Pazopanib in people with Pancreatic Cancer, run by Washington University School of Medicine 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 22 inclusion and 28 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 9 Jun 2015. 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 9 Jun 2015). 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?

Response Rate by RECIST Criteria. (time frame: Follow-up was approximately 9 weeks). 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 NCT01080248.

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 9 Jun 2015.

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