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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib malate
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, urethral cancer associated with invasive bladder cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm 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.

Outcomes

Primary Outcome Measures

Overall Objective Response
Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria

Secondary Outcome Measures

Full Information

First Posted
November 8, 2006
Last Updated
December 17, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00397488
Brief Title
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Official Title
Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Pfizer

4. Oversight

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Keywords
recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, urethral cancer associated with invasive bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Primary Outcome Measure Information:
Title
Overall Objective Response
Description
Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean F. Bajorin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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