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A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma

Information source: The Clatterbridge Cancer Centre NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Uveal Melanoma

Intervention: Dacarbazine (Drug); Sunitinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Clatterbridge Cancer Centre NHS Foundation Trust

Official(s) and/or principal investigator(s):
Ernest Marshall, Principal Investigator, Affiliation: The Clatterbridge Cancer Centre NHS Foundation Trust

Overall contact:
Matthew Bickerstaff, Phone: 0151 794 8934, Email: oasis@liv.ac.uk

Summary

Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat. Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma. This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.

Clinical Details

Official title: A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival

Secondary outcome:

Overall Survival

Overall Response Rate

Time to progression on first-line treatment compared to second-line treatment

Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy

Assessment of Adverse Events

Detailed description: 124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment. Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment (CT or MRI scan) until disease progression (according to RECIST 1. 1) has been identified. At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with histologically or cytologically confirmed unresectable, metastatic

uveal melanoma (histology must be available from a metastatic site)

- Patients with disease that is not amenable to surgery, radiation, or combined

modality therapy with curative intent No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)

- Patients who have received prior radiotherapy are eligible, however, measurable

lesions must not have been previously irradiated

- Life expectancy > 12 weeks ECOG Performance status 0, 1 or 2

- At least one measurable target lesion, for further evaluation according to the

Response Evaluation Criteria In Solid Tumours - RECIST version 1. 1 completed within

28 days of randomisation

- Aged > 18 years

- Adequate haematological, renal and liver function as defined below and performed

within 14 days of study inclusion: Hb > 10 g/dl, platelets > 100 x109/L, WCC > 3. 0 x109/L, ANC > 1. 5x109/L, Bili < 1. 5 x ULN, Alk phos < 5 x ULN, transaminases < 5 x ULN, Cr < 1. 5 x ULN

- Able to provide written informed consent

- 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 Exclusion Criteria: Patients who have:

- Conjunctival melanoma

- Received any previous systemic therapy for uveal melanoma

- Known leptomeningeal or brain metastases

- Patients with a history of prior malignant disease (unless 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)

- Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days

respectively, prior to study treatment administration

- Therapeutic anticoagulation for treatment of DVT/PE. Concomitant treatment with

therapeutic doses of anticoagulants (low dose warfarin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed)

- Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite

optimal medical therapy) or active uncontrolled infections

- 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 ischemic attack, or pulmonary embolism

- Clinically significant abnormal cardiac function with abnormal 12 lead ECG. Ongoing

cardiac dysrhythmias of NCI CTCAE grade 2, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females

- Any other serious or uncontrolled illness which, in the opinion of the investigator,

makes it undesirable for the patient to enter the trial

- Any medical or psychiatric condition which would influence the ability to provide

informed consent

- Pregnant or lactating women Lack of informed consent

- Any previous investigational agent within the last 12 weeks

Locations and Contacts

Matthew Bickerstaff, Phone: 0151 794 8934, Email: oasis@liv.ac.uk

Clatterbridge Centre for Oncology NHS Foundation Trust, Wirral CH63 4JY, United Kingdom; Recruiting
Ernest Marshall, Phone: 0151 334 1155, Email: emarshall@nhs.net
Ernest Marshall, Principal Investigator
Additional Information

Related Info: Liverpool Cancer Trials Unit

Related Info

Related Info

Starting date: October 2010
Last updated: March 9, 2012

Page last updated: August 23, 2015

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