Condition category
Cancer
Date applied
15/02/2006
Date assigned
04/04/2006
Last edited
22/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20800475

Publication citations

  1. 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.

Additional files

Editorial Notes