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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563823
• Other study ID #: CRCA-CCTC-CAMEL02
• Secondary ID: CDR0000576458EU-
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2007
• Last updated: August 1, 2013
• Start date: February 2006
• Est. completion date: October 2010

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• vatalanib

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Leicester Royal Infirmary	Leicester	England

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as assessed by RECIST every 8 weeks			No
Secondary	Time to progression			No
Secondary	Survival at 6 months and 1 year			No
Secondary	Overall survival			No
Secondary	Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks			Yes