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

Health Conditions
  • Metastatic Uveal Melanoma
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Drug; Dacarbazine; Dacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.; [Arm 1: Dacarbazine]; Drug; Sunitinib; Sunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity; [Arm 2: Sunitinib]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
SUAVE
Scientific Title
A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Secondary Trial Identifying Number
2008-008794-55; 8440; 75033520; 10/H0904/15
Website
http://www.lctu.org.uk; http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-possible-new-treatment-for-eye-cancer-uveal-melanoma-suave; http://public.ukcrn.org.uk/search
Study Funded By
The Clatterbridge Cancer Centre NHS Foundation Trust
Funder Type
Sorry, this information is not available
Study Sponsored By
The Clatterbridge Cancer Centre NHS Foundation Trust
Study Also Sponsored By
Cancer Research UK; Pfizer
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

08 Mar 2012

Last Updated

09 Mar 2012

Date Record Refreshed on UKCTG

25 Jul 2015