A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma | Recruiting
A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
SUAVE
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Metastatic Uveal Melanoma
Matthew Bickerstaff
0151 794 8934
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01551459
Primary Trial ID Number
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Dacarbazine, Drug : Sunitinib

Study Arm Groups : Arm 1: Dacarbazine, Arm 2: Sunitinib

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression Free Survival; Once all patients have been followed up for at least 3 months
Secondary Outcome Measures
  • Overall Survival; Analysis will take place once all patients have been followed up for at least 3 months; Overall Response Rate; Analysis will take place once all patients have been followed up for at least 3 months; Time to progression on first-line treatment compared to second-line treatment; Analysis will take place once all patients have been followed up for at least 3 months; Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy; Analysis will take place once all patients have been followed up for at least 3 months; Assessment of Adverse Events; Analysis will take place once all patients have been followed up for at least 3 months
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
124
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Wirral
CH63 4JY
Trial Contact(s)
Primary Trial Contact
Matthew Bickerstaff
oasis@liv.ac.uk
0151 794 8934
Other Trial Contacts
Sarah Jones
s.c.jones@liverpool.ac.uk
0151 795 5270
Countries Recruiting
United Kingdom
Scientific Title
A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
  • Pfizer
Other Study ID Numbers
2008-008794-55
Sponsor(s)
The Clatterbridge Cancer Centre NHS Foundation Trust
Key Dates

Recruitment Start Date

Oct 2010

Recruitment End Date

Apr 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

08 Mar 2012

Last Updated

09 Mar 2012