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Health Condition(s) or Problem
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Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma
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Lay Summary
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http://www.cancerhelp.org.uk/trials/a-study-looking-possible-new-treatment-for-eye-cancer-uveal-melanoma-suave (from ISRCTN)
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Who can enter the trial
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1. Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
2. Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent
3. No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
4. Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
5. Life expectancy greater than 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (for ECOG scale of performance)
7. At least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
8. Aged greater than 18 years, either sex
9. Adequate haematological, renal and liver function as defined below and performed within 14 days of study inclusion:
9.1. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000 mm3, white cell count (WCC) greater than 3.0 x 10^9/L, absolute neutrophil count (ANC) greater than 1.5 x 10^9/L
9.2. Bilirubin less than 1.5 x ULN, Alkaline phosphatase less than 5 x ULN, transaminases less than 5 x ULN
9.3. Creatinine less than 1.5 x ULN
10. Able to provide written informed consent
11. Females of child-bearing potential who have a negative pregnancy test prior to study entry and be using adequate contraception, which they agree to continue for 12 months after the study treatment
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Who cannot enter the trial
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1. Conjunctival melanoma
2. Received any previous systemic therapy for uveal melanoma
3. Known leptomeningeal or brain metastases
4. Patients with a history of prior malignant disease (only if they have had more than 3 years free of disease or have had adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix)
5. Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
6. Therapeutic anticoagulation for treatment of DVT/PE. Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin [Coumadin®] up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
7. Unstable systemic diseases including uncontrolled hypertension (greater than 150/100 mmHg despite optimal medical therapy) or active uncontrolled infections
8. Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, or pulmonary embolism
9. Clinically significant abnormal cardiac function with abnormal 12-lead electrocardiogram (ECG). Ongoing cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade more than or equal to grade 2, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to greater than 450 msec for males or greater than 470 msec for females.
10. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
11. Any medical or psychiatric condition which would influence the ability to provide informed consent
12. Pregnant or lactating women
13. Lack of informed consent
14. Any previous investigational agent within the last 12 weeks
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What will happen
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Control Arm (Dacarbazine): Dacarbazine 1000 mg/m^2 to be administered by IV on day 1, and repeated every 21 days until progression or unacceptable toxicity.
Experimental Arm (Sunitinib): Sunitinib 50 mg to be taken orally once a day for 28 days followed by 14 day break, until progression or unacceptable toxicity.
Study entry: single randomisation only
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Primary aim
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Progression free survival - 12 weekly scans will pick up progression according to RECIST 1.1. Analysis of primary outcome will be performed once all patients have been followed up for at least 3 months (expected to be Jan 2013).
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Secondary Aim
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1. Overall survival will be measured from date of randomisation to the date of death from any cause. Patients still alive at the time of analysis are censored at the date of the most recent follow up.
2. Overall response rate is defined as the proportion of complete (CR) or partial responders (PR) as defined by the RECIST version 1.1
3. AEs recorded following randomisation will be classified according to CTCAE version 4.0
4. Time to progression on first-line treatment (TTP1) compared to time to progression on second-line treatment (TTP2) for patients who receive cross-over therapy
5. Overall response rate on first-line treatment (RR1) compared to overall response rate on second-line treatment (RR2) for patients who receive cross-over therapy
Initial analysis by Data Monitoring Committee is planned for April 2011. Interim analysis for futility will be conducted after 50% of the events have been observed.
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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http://www.lctu.org.uk/trial/trials_open.asp?id=55
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Recruitment Status
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Completed
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Nation
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England
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Location
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Liverpool
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