Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as assessed by RECIST every 8 weeks | — |
Secondary
| Measure | 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 | — |
Countries
United Kingdom