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

Tracking Information
First Submitted Date ICMJE	November 22, 2007
First Posted Date ICMJE	November 26, 2007
Last Update Posted Date	August 2, 2013
Study Start Date ICMJE	February 2006
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 22, 2007)	Response rate as assessed by RECIST every 8 weeks
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00563823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 22, 2007)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
Official Title ICMJE	A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous 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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Melanoma (Skin)
Intervention ICMJE	Drug: vatalanib
Study Arms	Not Provided
Publications *	Cook N, Basu B, Biswas S, Kareclas P, Mann C, Palmer C, Thomas A, Nicholson S, Morgan B, Lomas D, Sirohi B, Mander AP, Middleton M, Corrie PG. A phase 2 study of vatalanib in metastatic melanoma patients. Eur J Cancer. 2010 Oct;46(15):2671-3. doi: 10.1016/j.ejca.2010.07.014. Epub 2010 Aug 25.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 22, 2007)	34
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2010
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00563823
Other Study ID Numbers ICMJE	CRCA-CCTC-CAMEL02; CDR0000576458 ( Registry Identifier: PDQ (Physician Data Query) ); EU-20787; EUDRACT-2005-004710-33; CCLG-Camel-02; ISRCTN00191981 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Cambridge University Hospitals NHS Foundation Trust
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
PRS Account	National Cancer Institute (NCI)
Verification Date	April 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP