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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| RPCI-I-95206 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.
After completion of study treatment, patients are followed for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug | oral |
| |
| neoadjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Sunitinib Malate (SM) | Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment. | 90 days |
| Safety of Surgery After 90 Days of Treatment With SM | Incident Rate: Intraoperative Complication Rate | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate After 90 Days of Treatment With SM | 90 days |
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DISEASE CHARACTERISTICS:
Newly diagnosed renal cell carcinoma
Primary tumor must be amenable to surgical removal
No history of or known spinal cord compression or carcinomatous meningitis OR evidence of symptomatic brain or leptomeningeal disease by CT scan or MRI
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
ANC ≥ 1,500/mm^3
Platelets ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
Total bilirubin ≤ 1.5 times ULN
Creatinine < 2 mg/dL OR creatinine clearance > 40 mL/min
Calcium ≤ 10.2 mg/dL
QTc interval < 500 msec
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 (male)-6 (female) months after completion of study treatment
No serious intercurrent illness including, but not limited to, any of the following:
None of the following conditions within the past 6 months:
No ongoing cardiac dysrhythmias NCI CTCAE version 3.0 ≥ grade 2
No hypertension that cannot be controlled by medications (i.e., diastolic blood pressure > 100 mm Hg despite optimal medical therapy)
No known HIV positivity
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Willie Underwood, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib Malate (Sunitinib) | sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib Malate (Sunitinib) | sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery neoadjuvant therapy: IV therapeutic conventional surgery: Surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety of Sunitinib Malate (SM) | Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment. | All treated and eligible patients | Posted | Number | 95% Confidence Interval | proportion of participants | 90 days |
|
|
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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 malate: oral neoadjuvant therapy: IV therapeutic conventional surgery: Surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Procedure |
IV |
|
| therapeutic conventional surgery | Procedure | Surgery |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Safety of Surgery After 90 Days of Treatment With SM | Incident Rate: Intraoperative Complication Rate | All treated and eligible patients | Posted | Number | 95% Confidence Interval | proportion of participants | 90 days |
|
|
|
| Secondary | Response Rate After 90 Days of Treatment With SM | All treated and eligible patients | Posted | Number | 95% Confidence Interval | proportion of participants | 90 days |
|
|
|
| 0 |
| 20 |
| 20 |
| 20 |
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| White blood cell disorder | Blood and lymphatic system disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Mucosal inflammation | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Depression postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Blood amylase | Investigations | Systematic Assessment |
|
| Blood amylase increased | Investigations | Systematic Assessment |
|
| Blood creatinine | Investigations | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | Systematic Assessment |
|
| Lipase | Investigations | Systematic Assessment |
|
| Lipase increased | Investigations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arteriovenous fistula operation | Surgical and medical procedures | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |