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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Vatalanib

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