Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Vatalanib 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. PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Primary To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib. Secondary To determine the time to progression in these patients. To determine the 6-month and 1-year survival of these patients. To determine the overall survival of these patients. To determine the safety and toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.

Official Title
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A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: vatalanib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic cutaneous melanoma Unresectable disease Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis) PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks Hemoglobin ≥ 10 g/dL Platelet count ≥ 100,000/mm^3 WBC ≥ 3,000/mm^3 ANC ≥ 1,500/mm^3 Bilirubin ≤ 1.5 x upper limit of normal (ULN) Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present) Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present) Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min Total urinary protein ≤ 500 mg by 24-hour urine collection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry No medical or psychiatric condition that precludes giving informed consent No history of renal disease (e.g., glomerulonephritis) or renal vascular disease No acute or chronic active liver disease (e.g., hepatitis or cirrhosis) No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following: Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen Unstable angina pectoris Symptomatic congestive heart failure Myocardial infarction within the past 6 months Serious uncontrolled cardiac arrhythmia Uncontrolled diabetes Active or uncontrolled infection No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions: Ulcerative disease Uncontrolled nausea Vomiting Diarrhea which might result in malabsorption Any known malabsorption syndrome Bowel obstruction Inability to swallow the capsules/tablets PRIOR CONCURRENT THERAPY: Recovered from all prior therapy Prior adjuvant therapy allowed Prior radiotherapy allowed Measurable target lesions must not have been irradiated No more than one line of prior systemic therapy for advanced melanoma More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent More than 2 weeks since prior surgery No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system Concurrent heparin allowed Concurrent radiotherapy for symptomatic disease is allowed, provided the lesions being irradiated contribute ≤ 20% of the sum of the longest diameter for all target lesions being used to determine response

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vatalanib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as assessed by RECIST every 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Survival at 6 months and 1 year |  |  | 
| Overall survival |  |  | 
| Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma