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

August 1, 2013 updated by: Cambridge University Hospitals NHS Foundation Trust

A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate as assessed by RECIST every 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Study Chair: Pippa Corrie, PhD, FRCP, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

November 22, 2007

First Submitted That Met QC Criteria

November 22, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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