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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00563823
First received: November 22, 2007
Last updated: August 1, 2013
Last verified: April 2008
  Purpose

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 Intervention Phase
Melanoma (Skin)
Drug: vatalanib
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as assessed by RECIST every 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Survival at 6 months and 1 year [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: February 2006
Study Completion Date: October 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563823

Locations
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
Investigators
Study Chair: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00563823     History of Changes
Other Study ID Numbers: CRCA-CCTC-CAMEL02, CDR0000576458, EU-20787, EUDRACT-2005-004710-33, CCLG-Camel-02, ISRCTN00191981
Study First Received: November 22, 2007
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014