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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563823
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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
Melanoma (Skin) Drug: vatalanib Phase 2

Detailed Description:



  • To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.


  • 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma
Study Start Date : February 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Response rate as assessed by RECIST every 8 weeks

Secondary Outcome Measures :
  1. Time to progression
  2. Survival at 6 months and 1 year
  3. Overall survival
  4. Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563823

United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Study Chair: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust

Publications of Results: Identifier: NCT00563823     History of Changes
Other Study ID Numbers: CRCA-CCTC-CAMEL02
CDR0000576458 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN00191981 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action