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

NCT01551459

Last updated date
Study Location
Clatterbridge Centre for Oncology NHS Foundation Trust
Wirral, , CH63 4JY, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Uveal Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Metastatic Uveal MelanomaA Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
NCT01551459
  1. Wirral,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Official Title  ICMJE A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Uveal Melanoma
Intervention  ICMJE
  • Drug: Dacarbazine
    Dacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
    Other Name: DTIC
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1: Dacarbazine
    Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
    Intervention: Drug: Dacarbazine
  • 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.
    Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 9, 2012)
124
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551459
Other Study ID Numbers  ICMJE 2008-008794-55
2008-008794-55 ( EudraCT Number )
8440 ( Other Identifier: UKCRN )
75033520 ( Other Identifier: ISRCTN )
10/H0904/15 ( Other Identifier: Sunderland Research Ethics Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Clatterbridge Cancer Centre NHS Foundation Trust
Study Sponsor  ICMJE The Clatterbridge Cancer Centre NHS Foundation Trust
Collaborators  ICMJE
  • Cancer Research UK
  • Pfizer
Investigators  ICMJE
Principal Investigator:Ernest MarshallThe Clatterbridge Cancer Centre NHS Foundation Trust
PRS Account The Clatterbridge Cancer Centre NHS Foundation Trust
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP