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Advanced Malignant MesotheliomaPhase 2NCT00459862

Pazopanib in Treating Patients With Malignant Pleural Mesothelioma

A Phase 2 study testing laboratory biomarker analysis and pazopanib hydrochloride in people with Advanced Malignant Mesothelioma and Localized Malignant Mesothelioma, 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 studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
laboratory biomarker analysis and pazopanib hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Mar 2007to May 2013
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

  • Histologically or cytologically confirmed malignant pleural mesothelioma:
  • Measurable disease
  • No progressive disease inside or outside of any prior radiation field
  • No symptomatic, untreated, or uncontrolled CNS metastases
  • Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT
  • Patients may begin study therapy as early as the next day after completion of WBRT
Show all 63Show fewer
  • ECOG performance status 0-2
  • Life expectancy >= 12 weeks
  • ANC >=1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 3,000/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT =< 2.5 times ULN
  • Alkaline phosphatase =< 2.5 times ULN
  • Creatinine =< 1.5 times ULN or creatinine clearance >= 50 mL/min
  • Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
  • No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication
  • Requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease
  • No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
  • Patients with a history of low-grade (Gleason score =< 6) localized prostate cancer are eligible even if diagnosed within the past 5 years
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
  • None of the following concurrent severe and/or uncontrolled medical conditions:
  • Serious or nonhealing wound, ulcer, or bone fracture
  • Abdominal fistula, diverticulosis, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • Poorly controlled diabetes
  • Interstitial pneumonia
  • Extensive and symptomatic interstitial fibrosis of the lung
  • No cardiovascular illness or complication, including any of the following:
  • Any history of cerebrovascular accident within the past 6 months
  • History of myocardial infarction (prior electrocardiographic evidence of myocardial injury)
  • History of cardiac arrhythmia (prior electrocardiographic evidence of abnormal heart rhythm)
  • Admission for unstable angina
  • Cardiac angioplasty or stenting within the past 12 months
  • NYHA class III-IV heart failure
  • Asymptomatic NYHA class II heart failure allowed
  • QTc prolongation (defined as a QTc interval ≥ 500 msecs) or other significant electrocardiogram abnormalities
  • Venous thrombosis within the past 12 weeks
  • No ancillary therapy considered investigational within the past 4 weeks
  • No symptomatic, untreated, or uncontrolled seizure disorder
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit study compliance
  • No significant traumatic injury within the past 4 weeks
  • No more than 1 prior systemic therapy for malignant pleural mesothelioma
  • No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
  • Insertion of a vascular access device is not considered major or minor surgery
  • No minor surgery within the past 2 weeks
  • Insertion of a vascular access device is not considered major or minor surgery
  • Prior palliative radiotherapy allowed
  • No prior palliative radiotherapy to the chest except for a maximum of 3 fractions of radiotherapy for superior vena cava syndrome
  • No concurrent therapeutic warfarin
  • Low molecular-weight heparin or prophylactic low-dose warfarin allowed
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy
  • No concurrent medications that act through the CYP450 system
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • PT/INR/PTT =< 1.2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No uncontrolled infection
  • No uncontrolled blood pressure (BP) (defined as systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg in spite of adequate anti-hypertensive therapy)
  • No other severe underlying disease that, in the judgment of the investigator, would limit study compliance

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Study of GW786034 in Patients With Malignant Pleural Mesothelioma

This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria.

II. Determine the clinical toxicities of this drug in this patient population.

SECONDARY OBJECTIVES:

  1. Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria.

II. Determine the response rate in patients treated with this drug. III. Determine the effect of this drug on overall survival and time to progression in these patients.

IV. Assess predictive markers of activity of this drug in these patients. V. Assess serologic markers of target inhibition by this drug in these patients.

VI. Determine the clinical toxicities of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis.

After completion of study therapy, patients are followed every 3 months.

Being tested
laboratory biomarker analysis, pazopanib hydrochloride
Medical subject headings
Mesothelioma, Malignant

What participants receive

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

  • laboratory biomarker analysisOther

    Correlative study

  • pazopanib hydrochlorideDrug

    Given orally

Study groups in NCT00459862
Study groupRoleWhat they receive
Arm IExperimentalPatients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Other: laboratory biomarker analysis; Drug: pazopanib hydrochloride

What is being measured

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

  1. Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)

    The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.

    Measured: 6 months

Secondary outcomes (5)

  1. Overall Survival

    Measured: From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years

  2. Progression-free Survival Assessed by RECIST

    Measured: From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years

  3. Determine the Clinical Toxicities of This Drug in This Participant Population.

    The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.

    Measured: Participants will be evaluated every cycle during treatment

  4. Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.

    Complete Response (CR): Disappearance of all target lesions.

    Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD.

    Measured: From study enrollment to the first date of disease progression

  5. Overall Response Rate

    To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met.

    Complete Response (CR): Disappearance of all target lesions.

    Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: Participants will be evaluated every cycle during treatment, 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 posted13 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionApr 2009
  4. Study completionMay 2013

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459862
Sponsor's protocol ID
NCI-2009-00656
Other IDs
NCI-2009-00656, CDR0000539269, N0623, N0623, U10CA025224
Status last verified
Oct 2013
First submitted
11 Apr 2007
Last updated
24 Feb 2015

Publications

  • Parikh K, Mandrekar SJ, Allen-Ziegler K, Esplin B, Tan AD, Marchello B, Adjei AA, Molina JR. A Phase II Study of Pazopanib in Patients with Malignant Pleural Mesothelioma: NCCTG N0623 (Alliance). Oncologist. 2020 Jun;25(6):523-531. doi: 10.1634/theoncologist.2019-0574. Epub 2019 Dec 24.

    PubMed 31872928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing laboratory biomarker analysis and pazopanib hydrochloride in people with Advanced Malignant Mesothelioma and Localized Malignant Mesothelioma, 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 63 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 Feb 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 5 Dec 2013). 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?

Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST) (time frame: 6 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 NCT00459862, which also lists 1 linked publication.

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 Feb 2015.

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