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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-06081 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Pfizer | INDUSTRY |
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.
OBJECTIVES:
Primary
Secondary
Determine the time to disease progression in patients treated with this regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:
Progressive metastatic disease
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:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dean F. Bajorin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Sunitinib in patients with metastatic urothelial carcinoma. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Sunitinib in patients with metastatic urothelial carcinoma. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Sunitinib in patients with metastatic urothelial carcinoma. | 34 | 78 | 67 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
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| Death not associated with CTCAE term-Disease progression | General disorders | CTC-3.0 | Systematic Assessment |
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| Dehydration | General disorders | CTC-3.0 | Systematic Assessment |
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| Distension/bloating, abdominal | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Extremity-lower (gait/walking) | General disorders | CTC-3.0 | Systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
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| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
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| Fistula, GI- Small bowel | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Bladder infection | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
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| Sepsis | General disorders | CTC-3.0 | Systematic Assessment |
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| Pneumonia | General disorders | CTC-3.0 | Systematic Assessment |
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| Infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTC-3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Back | General disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Bone | General disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Extremity-limb | General disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Head/headache | General disorders | CTC-3.0 | Systematic Assessment |
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| Pain - Pelvis | General disorders | CTC-3.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
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| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Anorexia | General disorders | CTC-3.0 | Systematic Assessment |
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| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
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| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Heartburn/dyspepsia | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hemorrhage, Urinary NOS | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Weight loss | General disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dean Bajorin | Memorial Sloan Kettering Cancer Center | 646-422-4333 | bajorind@mskcc.org |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Title | Measurements |
|---|---|
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