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

NCT00563823 | Completed Phase 2

• 6 other identifiers: CRCA-CCTC-CAMEL02CDR0000576458EU-20787EUDRACT-2005-004710-33CCLG-Camel-02ISRCTN00191981
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Response rate as assessed by RECIST every 8 weeks

Secondary Outcomes (4)

• 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

Interventions

vatalanib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (2)

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

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

  PMID: 20800475 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pippa Corrie, PhD, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2007
• First Posted: November 26, 2007
• Study Start: February 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2010
• Last Updated: August 2, 2013

Record last verified: 2008-04

Locations

GB (2)