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Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 2

Conditions

Transitional Cell Cancer of the Renal Pelvis and Ureter
Bladder Cancer
Urethral Cancer

Treatments

Drug: sunitinib malate

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT00397488
06-081
MSKCC-06081

Details and patient eligibility

About

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

Full description

OBJECTIVES:

Primary

  • Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
  • Determine the safety of this regimen in these patients.

Secondary

  • Determine the time to disease progression in patients treated with this regimen.

    • To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
    • To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Enrollment

78 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:

    • Bladder
    • Urethra
    • Ureter
    • Renal pelvis
  • Progressive metastatic disease

    • Progressive disease defined as new or progressive lesions on cross-sectional imaging
    • Progressed despite prior treatment with cytotoxic chemotherapy
  • Measurable disease

  • Previously treated disease, as defined by the following:

    • Received treatment with 1-4 cytotoxic agents

    • Prior therapy must have included ≥ 1 of the following:

      • Cisplatin
      • Carboplatin
      • Paclitaxel
      • Docetaxel
      • Gemcitabine hydrochloride
    • Prior cytotoxic agents in the perioperative or metastatic setting allowed and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or all as part of a single regimen

  • No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%

  • Absolute neutrophil count ≥ 1,000/mm³

  • Platelet count ≥ 100,000/mm³

  • Hemoglobin ≥ 8.0 g/dL

  • Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease is present)

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)

  • Creatinine ≤ 2.0 mg/dL

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • None of the following within the past 6 months:

    • Myocardial infarction
    • Severe or unstable angina
    • Coronary or peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • No ongoing cardiac dysrhythmias ≥ grade 2

  • No prolonged QTc interval on baseline ECG

  • No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal medical therapy

  • No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be maintained in the normal range with medication)

  • No known HIV- or AIDS-related illness or other active infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy or chemotherapy
  • At least 4 weeks since prior major surgery
  • No other concurrent investigational drugs
  • No concurrent participation in another clinical trial (supportive care trials or non-treatment trials [e.g., quality of life] allowed)
  • No concurrent therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg once daily for thromboembolic prophylaxis allowed)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

Sunitinib
Experimental group
Description:
This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma. Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population. A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle. Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression.
Treatment:
Drug: sunitinib malate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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