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

November 22, 2007
August 1, 2013
February 2006
September 2008   (final data collection date for primary outcome measure)
Response rate as assessed by RECIST every 8 weeks [ Designated as safety issue: No ]
Response rate as assessed by RECIST every 8 weeks
Complete list of historical versions of study NCT00563823 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Drug: vatalanib
Not Provided
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. Epub 2010 Aug 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
October 2010
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00563823
CRCA-CCTC-CAMEL02, CDR0000576458, EU-20787, EUDRACT-2005-004710-33, CCLG-Camel-02, ISRCTN00191981
Not Provided
Not Provided
Cambridge University Hospitals NHS Foundation Trust
Not Provided
Study Chair: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP