Cabozantinib for Advanced Urothelial Cancer

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Brief Title

Cabozantinib for Advanced Urothelial Cancer

Official Title

A Phase II Study of Cabozantinib (XL184) in Patients With Advanced/Metastatic Urothelial Carcinoma

Brief Summary

      Background:

      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is
      approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian
      tumors respond to it. Researchers want see if cabozantinib can be a safe and effective
      treatment for urothelial cancer.

      Objectives:

      - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer.

      Eligibility:

      - Individuals at least 18 years of age who have advanced urothelial cancer that has not
      responded to standard treatments.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected. Tumor tissue samples will also be collected. Imaging studies
           will also be performed.

        -  Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle.

        -  Treatment will be monitored with frequent blood tests and imaging studies.

        -  Participants will continue to take the study drug for as long as their cancer does not
           worsen and side effects are not too severe.
    

Detailed Description

      Background:

        -  In the United States, urothelial carcinoma (UC) of the bladder is the fourth most common
           malignancy in men and the ninth most common in women with an estimated 69,250 new cases
           and 14,990 deaths in the year 2011

        -  There is no Food and Drug Administration (FDA)-approved second line drug for patients
           with metastatic Urothelial Cancer (UC)

        -  Multiple lines of evidence support targeting angiogenesis in UC

        -  In human bladder cancer, overexpression of tyrosine-protein kinase (c-Met)/Axl/platelet
           derived growth factor receptor- (PDGFR)-alpha or c-Met alone showed significant
           correlation with poor survival

        -  Cabozantinib is a new chemical entity that inhibits multiple receptor tyrosine kinases
           with growth-promoting and angiogenic properties.

        -  The primary targets of cabozantinib are mesenchymal epithelial transition factor (MET),
           vascular endothelial factor receptor 2 (VEGFR2), and rearranged during transfection
           (RET)

      Objectives:

      - To determine the response rate of cabozantinib in patients with progressive urothelial
      cancer who have received prior cytotoxic chemotherapy

      Eligibility:

        -  Patients in cohort 1 must have a histologically confirmed diagnosis of metastatic,
           progressive urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

        -  Patients in cohort 2 must have a histologically confirmed diagnosis of bone only
           metastatic, urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

        -  Patients in cohort 3 must have a histologically confirmed diagnosis of non-transitional
           cell carcinoma cancer (including but not limited to squamous cell, neuroendocrine,
           adenocarcinoma including urachal and sarcomatoid) of the bladder, urethra, ureter, or
           renal pelvis.

        -  Patients must have been previously treated, as defined by treatment with at least one
           prior cytotoxic chemotherapy regimen or agent. Patients may have received any number of
           prior cytotoxic agents.

        -  18 years of age or older.

      Design:

        -  A maximum of 71subjects will be enrolled in this open label, non-randomized, phase II
           trial of 60 mg each day of cabozantinib. Up to 50 patients will be accrued to cohort 1
           (metastatic, progressive urothelial cancer. The remainder will be enrolled on
           exploratory cohorts 2 & 3, bone only metastatic urothelial disease and non transitional
           cell carcinoma (TCC) bladder cancer respectively, during the time the study is accruing
           patients for cohort 1. Note: Patients who tolerate cabozantinib at 60 mg daily during
           the first 2 cycles (first restaging time period) without (Bullet) grade 2 toxicity may
           undergo dose escalation to 80 mg daily at the discretion of the Principal Investigator.

        -  A Simon 2 stage design with alpha=0.05 and beta = 0.10 as acceptable error
           probabilities. Initially 21 subjects will be enrolled and followed for progression. If 2
           or more of cohort 1 subjects experiences a response, enrollment will continue until a
           total of 41 evaluable subjects with progressive urothelial cancer have been entered. 2-3
           patients per month may enroll on this trial; thus, 2 to 3 years is anticipated as the
           accrual period.

        -  Each patient will undergo response evaluation assessments with chest abdomen pelvis
           computed tomography (CAP CT) (or magnetic resonance imaging (MRI)) with or without
           18F-Sodium Fluoride (Na18F) positron emission tomography (PET CT) every 8 weeks while on
           active protocol therapy starting at baseline. Patients will undergo investigational
           Fludeoxyglucose, (FDG) PET/CT and PET/MRI (optional) at baseline, week 4 and week 8.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants With Overall Response

Secondary Outcome

 Overall Survival

Condition

Urothelial Carcinoma

Intervention

Cabozantinib

Study Arms / Comparison Groups

 Cabozantinib
Description:  Administered orally at a dose of 60 mg once daily on each day of a 28-day cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

69

Start Date

September 11, 2012

Completion Date

September 1, 2023

Primary Completion Date

December 11, 2017

Eligibility Criteria

        -  INCLUSION CRITERIA:

        Cohort 1 only (urothelial progressive disease)

          -  Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the
             bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any
             Clinical Laboratory Improvement Amendments (CLIA) certified lab.

          -  Patients must have progressive metastatic disease. Progressive disease will be defined
             as new or progressive lesions on cross-sectional imaging.

          -  Patients must have at least one measurable site of disease

        Cohort 2 only (Bone-only)

          -  Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the
             bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any CLIA
             certified lab.

          -  Patients must not have measurable progressive disease

          -  Patient must have appearance of at least one new bone lesion.

        Cohort 3 (Rare histologies)

          -  Patient must have a histologically confirmed diagnosis of non-transitional cell
             carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited
             to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid.
             Confirmation may be obtained from any CLIA certified lab.

          -  Patients must have progressive metastatic disease. Progressive disease will be defined
             as new or progressive lesions on cross-sectional imaging.

          -  Patients must have at least one measurable site of disease

        All cohorts

          -  Patients must have been previously treated, as defined by treatment with at least one
             prior cytotoxic regimen or agent.

          -  Age greater than or equal to 18 years. Because no dosing or adverse event data are
             currently available on the use of cabozantinib in patients <18 years of age, children
             are excluded from this study, but may be eligible for future pediatric trials.

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
             (Karnofsky greater than or equal to 60%

          -  Adequate organ function as defined by the following criteria:

          -  Hemoglobin greater than or equal to 9 g/dL

          -  Absolute neutrophil count (ANC) greater than or equal to 1500/microL

          -  Platelets greater than or equal to 75,000/L

          -  Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and
             serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than
             or equal to 3.0 times upper limit of normal (ULN); less than or equal to 5.0 times ULN
             in cases of liver metastases

          -  Total serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN).
             For subjects with known Gilberts disease or similar syndrome with slow conjugation of
             bilirubin, total bilirubin less than or equal to 3.0 mg/dL

          -  Serum creatinine less than or equal to 1.5 X institutional upper limits of normal or
             for patients with creatinine levels above 1.5 x institutional normal: creatinine
             clearance greater than or equal to 50 mL/min/1.73 m^2 by 24 hour urine collection or
             estimated creatinine clearance of greater than or equal to 50 mL/min. For creatinine
             clearance estimation , the Cockcroft and Gault equation should be used:

          -  Male: Creatinine Clearance (CrCl) (mL/min) = (140 - age) times wt (kg)/ (serum
             creatinine times 72)

          -  Female: Multiply above result by 0.85

          -  Urine protein/creatinine ratio (UPCR) less than or equal to 2

          -  Patient must be able to provide either archival tumor samples (haematoxylin and eosin
             (H&E) slides and one paraffin block or 10 unstained slides) or undergo tumor biopsy.

          -  Patient must be capable of understanding and complying with protocol requirements and
             is willing to give informed consent

          -  The effects of XL184 on the developing human fetus are unknown. For this reason and
             because tyrosine kinase inhibitors agents are known to be teratogenic, women of
             childbearing potential and men must agree to use adequate contraception prior to study
             entry and for the duration of study participation. Should a woman become pregnant or
             suspect she is pregnant while she or her partner is participating in this study, she
             should inform her treating physician immediately. Men treated or enrolled on this
             protocol must also agree to use adequate contraception prior to the study, for the
             duration of study participation, and 4 months after completion of XL184
             administration.

        Sexually active subjects (men and women) must agree to use medically accepted barrier
        methods of contraception (e.g., male or female condom) during the course of the study and
        for 4 months after the last dose of study drug(s), even if oral contraceptives are also
        used. All subjects of reproductive potential must agree to use both a barrier method and a
        second method of birth control during the course of the study and for 4 months after the
        last dose of study drug(s).

        - Women of childbearing potential must have a negative pregnancy test at screening. Women
        of childbearing potential include women who have experienced menarche and who have not
        undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
        bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea
        greater than or equal to 12 consecutive months. Note: women who have been amenorrheic for
        12 or more months are still considered to be of childbearing potential if the amenorrhea is
        possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other
        reversible reason.

        EXCLUSION CRITERIA:

          -  The subject has received cytotoxic chemotherapy (including investigational cytotoxic
             chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or
             nitrosoureas or mitomycin within 6 weeks before the first dose of study treatment.

          -  Prior treatment with cabozantinib

          -  Prior treatment with other small molecule inhibitors of Vascular Endothelial Growth
             Factor Receptors (VEGFR) within less than or equal to 2 years of study enrollment.

          -  The subject has received radiation therapy:

          -  to the thoracic cavity or gastrointestinal tract within 3 months before the first dose
             of study treatment

          -  to bone or brain metastasis within 14 days before the first dose of study treatment

          -  to any other site(s) within 28 days before the first dose of study treatment

          -  The subject has received radionuclide treatment within 6 weeks before the first dose
             of study treatment

          -  The subject has received prior treatment with a small molecule kinase inhibitor or a
             hormonal therapy (including investigational kinase inhibitors or hormones) within 14
             days or five half-lives of the compound or active metabolites, whichever is longer,
             before the first dose of study treatment.

          -  The subject has received any other type of investigational agent within 28 days before
             the first dose of study treatment.

          -  The subject has not recovered to baseline or Common Terminology Criteria in Adverse
             Events (CTCAE). Grade 1 from toxicity due to all prior therapies except alopecia and
             other non-clinically significant AEs.

          -  The subject has a primary brain tumor

          -  The subject has active brain metastases, leptomeningeal or epidural disease (Note:
             Subjects with brain metastases previously treated with whole brain radiation or
             radiosurgery or subjects with epidural disease previously treated with radiation or
             surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks
             before starting study treatment are eligible. Neurosurgical resection of brain
             metastases or brain biopsy is permitted if completed at least 3 months before starting
             study treatment. Baseline brain scans are not required to confirm eligibility.)

          -  The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial
             thromboplastin time (PTT) test greater than or equal to 1.3 times the laboratory upper
             limit of normal (ULN) within 7 days before the first dose of study treatment.

          -  The subject requires treatment, in therapeutic doses, with oral anticoagulants such as
             warfarin prior to initiation of protocol therapy. Low dose aspirin (less than or equal
             to 81 mg/day), lowdose warfarin (less than or equal to 1 mg/day), and low molecular
             weight heparin (LMWH) are permitted. Subjects will be permitted to use anticoagulation
             as described if treatment is required while they are enrolled on the protocol.

          -  The subject requires chronic concomitant treatment of strong Cytochrome P450 3A4
             (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin,
             rifapentine, phenobarbital, and St. John's Wort).

        Because the lists of these agents are constantly changing, it is important to regularly
        consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/;
        medical reference texts such as the Physicians Desk Reference may also provide this
        information. As part of the enrollment/informed consent procedures, the patient will be
        counseled on the risk of interactions with other agents, and what to do if new medications
        need to be prescribed or if the patient is considering a new over-the counter medicine or
        herbal product.

          -  The subject has experienced any of the following within 3 months before the first dose
             of study treatment:

          -  clinically-significant hematemesis or gastrointestinal bleeding

          -  hemoptysis of greater than or equal to 0.5 teaspoon (greater than or equal to 2.5 mL)
             of red blood

          -  any other signs indicative of pulmonary hemorrhage

          -  The subject has tumor invading (or concern for invasion) major blood vessels

          -  Other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the Investigator would make the patient inappropriate for entry into
             this study.

          -  The subject has evidence of tumor invading the gastrointestinal (GI) tract (esophagus,
             stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or
             endobronchial tumor within 28 days before the first dose of cabozantinib.

          -  The subject is unable to swallow tablets

          -  The subject has a corrected Q wave, T wave (QT) interval calculated by the Fridericia
             formula (QTcF) >500 ms within 28 days before treatment initiation.

          -  The subject has a previously identified allergy or hypersensitivity to components of
             the study treatment formulation.

          -  The subject is unable or unwilling to abide by the study protocol or cooperate fully
             with the investigator or designee.

          -  The subject has had within 2 years before the start of study treatment evidence of
             another malignancy which required systemic treatment

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible because of the potential for pharmacokinetic interactions with
             the study agents. In addition, these patients are at increased risk of lethal
             infections when treated with marrow-suppressive therapy. Appropriate studies will be
             undertaken in patients receiving combination antiretroviral therapy when indicated.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Andrea B Apolo, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01688999

Organization ID

120205

Secondary IDs

12-C-0205

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Andrea B Apolo, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

September 2020