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

NCT ID: NCT00563823

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-10-31

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.

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

vatalanib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Pippa Corrie, PhD, FRCP

Role: STUDY_CHAIR

Cambridge University Hospitals NHS Foundation Trust

Locations

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Leicester Royal Infirmary

Leicester, England, United Kingdom

Countries

United Kingdom

References

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/j.ejca.2010.07.014. Epub 2010 Aug 25.

Reference Type: RESULT

PMID: 20800475 (View on PubMed)

Other Identifiers

CDR0000576458

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20787

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2005-004710-33

Identifier Type: -

Identifier Source: secondary_id

CCLG-Camel-02

Identifier Type: -

Identifier Source: secondary_id

ISRCTN00191981

Identifier Type: REGISTRY

Identifier Source: secondary_id

CRCA-CCTC-CAMEL02

Identifier Type: -

Identifier Source: org_study_id