Contact information
Type
Scientific
Primary contact
Dr Pippa Corrie
ORCID ID
Contact details
Oncology Centre
Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216083
pippa.corrie@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00563823
Protocol/serial number
CAMEL 02
Study information
Scientific title
Acronym
PTK787
Study hypothesis
To determine the efficacy of PTK787 in patients with metastatic cutaneous melanoma in terms of objective response rate
Ethics approval
Approved by the South East Medical Research Ethics Committee on 13/02/2006, reference number 06/MRE01/10
Study design
Interventional, open-label, uncontrolled, phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Metastatic cutaneous melanoma
Intervention
Prior to commencing treatment with PTK787/ZK222584, patients will undergo the following interventions:
1. Dynamic contrast enhanced magnetic resonance imaging (MRI) scan of liver metastases
2. Tumour and adjacent tissue biopsy
3. Blood sample to measure soluble markers
Intervention type
Drug
Phase
Phase II
Drug names
PTK787/ZK222584
Primary outcome measure
Objective response rate
Secondary outcome measures
1. Time to progression
2. Survival at six months and one year
3. Overall survival
4. Safety and toxicity
5. Correlation of pharmacological and genetic markers to response
6. Correlation of tumour vascularity and permeability to response
Overall trial start date
03/01/2006
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Life expectancy >12 weeks
2. Performance status 0, 1 or 2 (Eastern Cooperative Oncology Group [ECOG] performance scale)
3. Presence of one or more bi-dimensionally measurable lesions, either clinically or radiologically (by chest x-ray, computerised tomography [CT] or conventional magnetic resonance imaging [MRI] scan as appropriate) using response evaluation criteria in solid tumors (RECIST) criteria
4. Age >18 years
5. Hb >10 g/dl, platelets >100,000 mm^3, white cell count (WCC) >3.0 x 10^9 /l, absolute neutrophil count (ANC) >1.5 x 10^9 /l
6. Bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <3 x ULN, transaminases <3 x ULN, (or alkaline phosphatase and transaminases <5 if liver metastases are present)
7. Creatinine <1.5 x ULN
8. Measured creatinine clearance >50 ml/min and total urinary protein <500 mg per 24 hours
9. Written informed consent provided by the patient
10. Patients of both genders with reproductive potential not employing an effective method of birth control, barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
11. Prior adjuvant therapy is allowed, as long as it was completed at least six months previously
12. One line of prior chemotherapy for advanced disease is allowed, as long as the best response to this treatment was complete response, partial response or stable disease, determined after a minimum of two cycles of planned treatment, using RECIST criteria
13. Prior radiotherapy is allowed, however measurable target lesions must not have been irradiated
14. Patients must not have a history of other malignant disease other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
34
Participant exclusion criteria
1. Patients who have received a first line therapy for advanced disease, when the initial response was documented to be disease progression, using RECIST criteria
2. Any previous chemotherapy, immunotherapy or investigational agent within the last four weeks
3. Any other serious or uncontrolled illness, which in the opinion of the investigator makes it undesirable for the patient to enter the trial
4. Any medical or psychiatric condition, which would influence the ability to provide informed consent
5. Patients with a history of renal (e.g. glomerulonephritis) or renal vascular disease
6. Acute or chronic active liver disease (e.g. hepatitis, cirrhosis)
7. Surgery within two weeks of entry into the trial
8. Incomplete recovery from previous surgery or non-surgical treatment
9. History or presence of central nervous system (CNS) disease i.e. primary brain tumour, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis
10. Any of the following concurrent severe and/or uncontrolled medical conditions, which could compromise participation in the trial:
a. Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
b. Unstable angina pectoris
c. Symptomatic congestive heart failure
d. Myocardial infarction under six months prior to randomisation
e. Serious uncontrolled cardiac arrhythmia
f. Uncontrolled diabetes
g. Active or uncontrolled infection
h. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhoea which might result in malabsorption, any known malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
11. Patients who are taking warfarin or other similar oral anticoagulants that are metabolised by the cytochrome P450 system, heparin is acceptable
12. Pregnant or lactating women
13. Women of childbearing potential must have a negative serum pregnancy test with 48 hours of trial entry
Recruitment start date
03/01/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Addenbrookes Charities Research Advisory Committee
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20800475
Publication citations
-
Results
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, 46, 15, 2671-2673, doi: 10.1016/j.ejca.2010.07.014.