Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.
Secondary
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To determine the time to progression in these patients.
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To determine the 6-month and 1-year survival of these patients.
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To determine the overall survival of these patients.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Response rate as assessed by RECIST every 8 weeks []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed metastatic cutaneous melanoma
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Unresectable disease
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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
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No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis)
PATIENT CHARACTERISTICS:
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ECOG performance status 0-2
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Life expectancy ≥ 12 weeks
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Hemoglobin ≥ 10 g/dL
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Platelet count ≥ 100,000/mm^3
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WBC ≥ 3,000/mm^3
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ANC ≥ 1,500/mm^3
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Bilirubin ≤ 1.5 x upper limit of normal (ULN)
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Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present)
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Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present)
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Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
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Total urinary protein ≤ 500 mg by 24-hour urine collection
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective barrier contraception
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No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
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No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry
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No medical or psychiatric condition that precludes giving informed consent
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No history of renal disease (e.g., glomerulonephritis) or renal vascular disease
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No acute or chronic active liver disease (e.g., hepatitis or cirrhosis)
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No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:
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Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
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Unstable angina pectoris
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Symptomatic congestive heart failure
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Myocardial infarction within the past 6 months
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Serious uncontrolled cardiac arrhythmia
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Uncontrolled diabetes
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Active or uncontrolled infection
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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:
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Ulcerative disease
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Uncontrolled nausea
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Vomiting
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Diarrhea which might result in malabsorption
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Any known malabsorption syndrome
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Bowel obstruction
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Inability to swallow the capsules/tablets
PRIOR CONCURRENT THERAPY:
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Recovered from all prior therapy
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Prior adjuvant therapy allowed
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Prior radiotherapy allowed
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Measurable target lesions must not have been irradiated
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No more than one line of prior systemic therapy for advanced melanoma
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More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent
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More than 2 weeks since prior surgery
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No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system
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Concurrent heparin allowed
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addenbrooke's Hospital | Cambridge | England | United Kingdom | CB2 2QQ |
| 2 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
Sponsors and Collaborators
- Cambridge University Hospitals NHS Foundation Trust
Investigators
- Study Chair: Pippa Corrie, PhD, FRCP, Cambridge University Hospitals NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRCA-CCTC-CAMEL02
- CDR0000576458
- EU-20787
- EUDRACT-2005-004710-33
- CCLG-Camel-02
- ISRCTN00191981