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| [ ...Back to search results ] | [ Print-friendly version ] |
| A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN00191981 |
| Date ISRCTN assigned | 04/04/2006 |
| Local reference number(s) | CAMEL 02 |
| Public title | A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma |
| Scientific title | |
| Acronym | PTK787 |
| Disease/condition/study domain | Metastatic cutaneous melanoma |
| Study hypothesis | To determine the efficacy of PTK787 in patients with metastatic cutaneous melanoma in terms of objective response rate |
| Design/methodology | Interventional, open-label, uncontrolled, phase II study |
| Research ethics review | Approved by the South East Medical Research Ethics Committee on 13/02/2006, reference number 06/MRE01/10 |
| Countries of trial | United Kingdom |
| Participants - 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 mm3, 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 03/01/2006 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Target number of participants | 34 |
| Interventions | 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 |
| Primary outcome measure(s) | Objective response rate |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Addenbrookes Charities Research Advisory Committee |
| Sponsor name | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Sponsor details | Trust Research and Development Department Box 146 Addenbrookes Hospital Hills Road Cambridge United Kingdom CB2 2QQ |
| Contact name | Dr Pippa Corrie |
| Contact details | Oncology Centre Box 193 Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital Hills Road Cambridge United Kingdom CB2 2QQ |
| Contact telephone | +44 (0)1223 216083 |
| Contact fax | +44 (0)1223 348071 |
| Contact email | pippa.corrie@addenbrookes.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN00191981 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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