Clinical trial NCT00755976: Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
Official title: Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2008-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
timeFrame: Ongoing throughout trial
Secondary outcomes:
measure: Toxicity according to NCI CTCAE v.3.0
timeFrame: Ongoing throughout trial
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: National Institute for Cellular Biotechnology at Dublin City University
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Mid-Western Cancer Centre at Mid-Western Regional Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
affiliation: St Vincent's University Hospital
name: John Crown, MD
role: PRINCIPAL_INVESTIGATOR
References: