Melanoma (Skin)Phase 2NCT00755976
Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
A Phase 2 study testing epirubicin hydrochloride, sulindac and immunologic technique in people with Melanoma (Skin), run by Cancer Trials Ireland at 10 sites in Ireland.
Trial summary
RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- epirubicin hydrochloride, sulindac and immunologic technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 10 sitesIreland
- Study dates
- Aug 2007to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma
- Metastatic disease
- Tumor block available for resistance marker analysis
- Measurable or evaluable disease
- No active brain metastases except for patients who have undergone successful complete excision of solitary brain metastasis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- ANC > 1 x 10^9/L
- Platelet count > 100 x 10^9/L
- Hemoglobin > 9 g/dL
- Serum bilirubin normal (except in patients with benign congenital hyperbilirubinemia)
- Not pregnant or nursing
- Negative pregnancy test
- Normal cardiac ejection fraction, cardiac wall motion, and ECG
- No active heart disease, including any of the following:
- Myocardial infarction within the past year
- Pericarditis
- Existing hypertension requiring treatment
- No other active serious medical or psychiatric disease
- No prior or concurrent malignancy, other than basal cell carcinoma of the skin , or carcinoma in-situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior anthracycline or anthracenedione-containing chemotherapy regimen
- No prior cardiac radiotherapy
- No major surgery within the past 2 weeks
- No participation in any clinical trial within the past 4 weeks
- No other concurrent anticancer therapies
- Concurrent bisphosphonates allowed in patients with bony metastases with extra-osseous measurable or evaluable lesions
- No other concurrent experimental medications
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Cork University Hospital
Cork
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24
St. Vincent's University Hospital
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
St. James's Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
National Institute for Cellular Biotechnology at Dublin City University
Dublin, 9
Galway University Hospital
Galway
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, 0009
Waterford Regional Hospital
Waterford
About this study
Official title: Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sulindac together with epirubicin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin works in treating patients with metastatic malignant melanoma.
Read the detailed description
OBJECTIVES:
Primary
- To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in patients with metastatic malignant melanoma.
Secondary
- To characterize the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sulindac 2 hours prior to receiving epirubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Previously collected tumor blocks are assessed for cancer resistance markers by IHC.
After completion of study treatment, patients are followed for 1 month, and then every 3 months thereafter.
- Conditions
- Melanoma (Skin)
- Being tested
- epirubicin hydrochloride, sulindac, immunologic technique
- Keywords
- stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epirubicin hydrochlorideDrug
sulindacDrug
immunologic techniqueOther
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg | Experimental | Not described Receives: Drug: epirubicin hydrochloride; Drug: sulindac; Other: immunologic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
The interim analysis will study the objective response to treatment in the first cohort of 29 patients. Response will be assessed according to NCI -Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
Measured: Ongoing throughout trial
Secondary outcomes (1)
Toxicity according to NCI CTCAE v.3.0
Measured: Ongoing throughout trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John Crown, MD, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755976
- Sponsor's protocol ID
- 06-03 ICORG
- Other IDs
- ICORG-06-03, EUDRACT-2006-006051-12, EU-20876
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2008
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00755976
- Acronym / sponsor ID
- 06-03 ICORG
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sulindac together with epirubicin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin works in treating patients with metastatic malignant melanoma.
Detailed description
OBJECTIVES:
Primary
- To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in patients with metastatic malignant melanoma.
Secondary
- To characterize the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sulindac 2 hours prior to receiving epirubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Previously collected tumor blocks are assessed for cancer resistance markers by IHC.
After completion of study treatment, patients are followed for 1 month, and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg | Experimental | Drug: epirubicin hydrochloride, Drug: sulindac, Other: immunologic technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epirubicin hydrochloride | Drug | Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg |
| sulindac | Drug | Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg |
| immunologic technique | Other | Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg |
Primary outcome
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
Time frame: Ongoing throughout trial
The interim analysis will study the objective response to treatment in the first cohort of 29 patients. Response will be assessed according to NCI -Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
1 secondary outcome
Toxicity according to NCI CTCAE v.3.0
Time frame: Ongoing throughout trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Crown, MD principal investigator
St Vincent's University Hospital, Ireland
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epirubicin hydrochloride, sulindac and immunologic technique in people with Melanoma (Skin), run by Cancer Trials Ireland at 10 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria (time frame: Ongoing throughout trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.