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Sorafenib + Tamoxifen + Cisplatin for Melanoma
Phase 2
Waitlist Available
Led By Edward F. McClay, MD
Research Sponsored by San Diego Pacific Oncology & Hematology Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of melanoma
Surgically rendered disease free
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and efficacy of giving Sorafenib in conjunction with Tamoxifen and Cisplatin to patients with high-risk stage III Melanoma.
Who is the study for?
This trial is for patients with high-risk stage III melanoma who've had surgery within the last 8 weeks and are now tumor-free. They should be relatively healthy (ECOG status 0-2), have good kidney and liver function, stable blood counts, not pregnant or breastfeeding, no severe illnesses or other cancers in the past 5 years (except certain skin/cervical cancers), and no recent heart attacks or thromboembolic events.Check my eligibility
What is being tested?
The study tests how well sorafenib works alongside tamoxifen and cisplatin to prevent melanoma from returning after surgery. Sorafenib blocks enzymes that tumors need to grow; tamoxifen and cisplatin are chemotherapy drugs that kill or stop cancer cells from dividing.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, diarrhea, increased risk of bleeding or infection due to low blood cell counts, skin reactions at drug application sites, high blood pressure, hand-foot syndrome (redness/swelling of palms/soles), hair loss from chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with melanoma.
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I have had surgery to remove all signs of my cancer.
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I am able to get out of my bed or chair and move around.
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My condition is high-risk, stage III.
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My kidney function is normal or only slightly reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Relapse-free survival
Toxicity
Find a Location
Who is running the clinical trial?
San Diego Pacific Oncology & Hematology AssociatesLead Sponsor
3 Previous Clinical Trials
184 Total Patients Enrolled
Edward F. McClay, MDPrincipal InvestigatorSan Diego Pacific Oncology & Hematology Associates
3 Previous Clinical Trials
184 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously taken tamoxifen, sorafenib, or cisplatin.Your platelet count is at least 100,000 per cubic millimeter.I haven't had any cancer except for skin (non-melanoma) or cervical cancer in the last 5 years.I have been diagnosed with melanoma.Your liver function tests are not more than three times the upper limit of normal.I am currently undergoing radiotherapy or surgery.I am on medication for congestive heart failure.I need extra oxygen to breathe properly.I do not have any serious illnesses that could make treatment unsafe for me.I have not had a blood clot in the last 6 months.You have a long-term weakened immune system.I had surgery within the last 8 weeks.I have had surgery to remove all signs of my cancer.I am able to get out of my bed or chair and move around.My cancer has spread and can be measured.Your hemoglobin level is at least 9.0 grams per deciliter.I currently have an infection.I feel short of breath even when I'm resting.I have had a heart attack in the last 6 months.You must have a negative pregnancy test.My condition is high-risk, stage III.Your ANC (absolute neutrophil count) is at least 1,200 per cubic millimeter.My kidney function is normal or only slightly reduced.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with this treatment option?
"The safety of this treatment, as estimated by our team at Power, falls at a 2. This is because, while there is some data supporting safety, there is no evidence yet if the treatment is effective."
Answered by AI
Are people currently being recruited for this experiment?
"According to the listing on clinicaltrials.gov, this study is not enrolling patients at the moment. The trial was first posted on April 1st 2007 and last edited January 9th 2014. There are 788 other trials that are currently open for recruitment."
Answered by AI
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