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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Clatterbridge Centre for Oncology NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cancer Research UK
Pfizer
Information provided by (Responsible Party):
Clatterbridge Centre for Oncology NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01551459
First received: March 8, 2012
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Uveal Melanoma
Drug: Dacarbazine
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Clatterbridge Centre for Oncology NHS Foundation Trust:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Once all patients have been followed up for at least 3 months ] [ Designated as safety issue: No ]
    The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free survival time will be calculated to date of progressive disease or date of death (whichever occurs first) and will be counted as events in the analysis. Patients still alive with no evidence of progression at the time of their last visit are censored at the time of the most recent information.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Analysis will take place once all patients have been followed up for at least 3 months ] [ Designated as safety issue: No ]
    Overall survival will be measured from date of randomisation to the date of death from any cause. Patients still alive at the time of the analysis are censored at the date of the most recent follow-up.

  • Overall Response Rate [ Time Frame: Analysis will take place once all patients have been followed up for at least 3 months ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of complete (CR) or partial responders (PR) as defined by the RECIST version 1.1

  • Time to progression on first-line treatment compared to second-line treatment [ Time Frame: Analysis will take place once all patients have been followed up for at least 3 months ] [ Designated as safety issue: No ]
    Time to progression on first-line treatment compared to second-line treatment for patients who receive cross-over therapy.

  • Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy [ Time Frame: Analysis will take place once all patients have been followed up for at least 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Analysis will take place once all patients have been followed up for at least 3 months ] [ Designated as safety issue: Yes ]
    Adverse Events recorded following randomisation will be classified using NCI CTCAE version 4.


Estimated Enrollment: 124
Study Start Date: October 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Dacarbazine
Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
Drug: Dacarbazine
Dacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
Other Name: DTIC
Experimental: Arm 2: Sunitinib
Sunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity.
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
Other Names:
  • Sutent
  • Sunitinib Malate

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551459

Contacts
Contact: Matthew Bickerstaff 0151 794 8934 oasis@liv.ac.uk
Contact: Sarah Jones 0151 795 5270 s.c.jones@liverpool.ac.uk

Locations
United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH63 4JY
Contact: Ernest Marshall    0151 334 1155    emarshall@nhs.net   
Principal Investigator: Ernest Marshall         
Sponsors and Collaborators
Clatterbridge Centre for Oncology NHS Foundation Trust
Cancer Research UK
Pfizer
Investigators
Principal Investigator: Ernest Marshall Clatterbridge Centre for Oncology NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Clatterbridge Centre for Oncology NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01551459     History of Changes
Other Study ID Numbers: 2008-008794-55, 2008-008794-55, 8440, 75033520, 10/H0904/15
Study First Received: March 8, 2012
Last Updated: March 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Clatterbridge Centre for Oncology NHS Foundation Trust:
Uveal
Melanoma
Metastatic
Sunitinib

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Eye Diseases
Eye Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014