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Bladder CancerPhase 2NCT01108055

Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer

A Phase 2 study testing Pazopanib (GW786034) and Paclitaxel in people with Bladder Cancer and Bladder (Urothelial, Transitional Cell) Cancer, run by Sandy Srinivas at 2 sites 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

We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pazopanib (GW786034) and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesUnited States
Study dates
Apr 2010to Jul 2015
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 confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra). Mixed histology is allowed as long as the predominant histology is TCC
  • First recurrence after treatment with a maximum of two chemotherapeutic regimens.
  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
  • Procedures conducted as part of the subject's routine clinical management (eg, blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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  • Measurable disease criteria by RECIST criteria
  • Adequate organ system function as defined below
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Platelets ≥ 100 X 10^9/L
  • Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN
  • aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN
  • Serum creatinine ≤ 1.8 mg/dL
  • Urine Protein to Creatinine Ratio (UPC) < 1
  • A female is eligible to enter and participate in this study if she is of non-childbearing potential (ie, physiologically incapable of becoming pregnant). This includes any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Menopause
  • Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • An intrauterine device with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.
  • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).

Who cannot join

  • History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer Malignancies that have undergone a putative surgical cure (ie, localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Medical Monitor
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding
  • Clinically significant gastrointestinal abnormalities that may affect absorption of the investigational product
  • Presence of uncontrolled infection.
  • Prolongation of corrected QT interval (QTc) > 480 milliseconds. On antiarrhythmics or medications known to prolong QT interval
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  • 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)
  • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥ 140 mmHg or diastolic blood pressure (DBP) of ≥ 90mm Hg].
  • History of cerebrovascular accident, hemoptysis, cerebral hemorrhage, clinically significant GI bleed, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture
  • Evidence of active bleeding or bleeding diathesis.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to procedures.
  • Patients on strong CYP3A4 inhibitors
  • Uncorrected abnormal electrolytes: K, Mg and Ca
  • Prior treatment with taxane chemotherapy
  • Treatment with any of the following anti-cancer therapies:
  • radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase II Study of Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer

We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.

Read the detailed description

Based on the results from the Phase 1 study of pazopanib combined with paclitaxel and the activity of paclitaxel in urothelial cancer, testing this regimen in a disease where there is an unmet need appears appropriate.

Being tested
Pazopanib (GW786034), Paclitaxel
Medical subject headings
Urinary Bladder Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Pazopanib (GW786034)Drug

    Also called GW786034

    Cycle of 28 days. Pazopanib: 800mg/day

  • PaclitaxelDrug

    Also called Taxol

    Cycle of 28 days Paclitaxel: 80mg/m2 days 1,8 and 15

Study groups in NCT01108055
Study groupRoleWhat they receive
pazopanib + paclitaxelExperimentalCycle of 28 days. Pazopanib: 800mg daily Cycle of 28 days Paclitaxel: 80mg/m2 on days 1,8 and 15
Receives: Drug: Pazopanib (GW786034); Drug: Paclitaxel

What is being measured

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

  1. Objective Tumor Response

    The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:

    • Complete response (CR) = Disappearance of all target lesions
    • Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions
    • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
    • Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR).

    Measured: Every 8 weeks

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Measured: 4 years

  2. Overall Response Rate

    The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:

    • Complete response (CR) = Disappearance of all target lesions
    • Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions
    • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
    • Stable disease (SD) = Small changes that do not meet above criteria Tumor response rate by each response criteria.

    Measured: 4 years

  3. Overall Survival

    Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).

    Measured: 4 years

  4. Median Overall Survival (OS) by Bellmunt Score

    Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates.

    The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen.

    The risk factors used to calculate the Bellmunt score include:

    • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
    • Presence of liver metastases
    • Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node)
    • Lymph node-only involvement
    • Hemoglobin concentration < 10 g/dL

    The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors.

    Measured: 4 years

Timeline

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

  1. First posted21 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2015
  4. Study completionJul 2015

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108055
Sponsor's protocol ID
IRB-17472
Other IDs
SU-04152010-5683, BLDR0010
Status last verified
May 2017
First submitted
15 Apr 2010
Last updated
9 Jun 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib (GW786034) and Paclitaxel in people with Bladder Cancer and Bladder (Urothelial, Transitional Cell) Cancer, run by Sandy Srinivas at 2 sites 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 26 inclusion and 24 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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2017). 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?

Objective Tumor Response (time frame: Every 8 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 NCT01108055.

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 2017.

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