Testing Two Different Schedules of Dabrafenib and Trametinib for Advanced Skin Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02196181
This study is exploring whether taking the medications dabrafenib and trametinib continuously or with breaks is more effective for treating advanced melanoma with a specific BRAF mutation that cannot be surgically removed.
Patient Parameters
| Parameter | Options |
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Program Overview
This clinical trial is comparing two ways of taking the medications dabrafenib and trametinib for treating advanced melanoma with a BRAF mutation. The study aims to find out if taking these drugs continuously or with breaks (intermittently) is more effective in stopping the growth of cancer cells. Both medications work by blocking certain enzymes that help cancer cells grow. The trial will help determine if intermittent dosing is as effective as continuous dosing for patients with stage III-IV melanoma that cannot be removed by surgery.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when taking dabrafenib and trametinib either continuously or with breaks. Researchers will also look at the side effects of both dosing schedules, including the frequency and severity of fever. They will also compare how well the cancer responds to each treatment schedule and overall survival rates.
The study will also explore whether certain molecular changes in the cancer are more common in patients taking the drugs continuously compared to those taking them intermittently. Researchers will collect blood and tissue samples to study these changes and their impact on treatment outcomes.
Participants will be randomly assigned to one of two groups:
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Continuous Dosing Group: Patients will take dabrafenib twice daily and trametinib once daily without breaks for 56-day cycles, as long as the treatment is effective and side effects are manageable. They will have regular scans and tests to monitor their health and the cancer's response.
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Intermittent Dosing Group: Patients will take dabrafenib twice daily and trametinib once daily for the first 7 days and then again from days 29 to 56 of each 56-day cycle. They will also have regular scans and tests to monitor their health and the cancer's response.
After completing the study treatment, patients will have follow-up visits every 6 months for 3 years, and then once a year for 2 more years.
Eligibility Criteria
Inclusion Criteria
- Must have advanced melanoma (stage III or IV) with a specific BRAF mutation that cannot be removed by surgery.
- Must have the BRAF V600E or V600K mutation confirmed by a certified lab.
- Must have measurable cancer as shown by scans.
- Must not have taken BRAF or MEK inhibitors before.
- Must be 18 years or older.
- Must have good blood counts and organ function based on recent tests.
- Must not have any serious heart or lung conditions.
- Must not be pregnant or breastfeeding and must agree to use effective birth control.
- Must be able to take oral medications and not have any digestive issues that affect absorption.
- Must not have any other active cancers, except for certain skin cancers or cancers in remission.
- Must be willing to provide blood and tissue samples for research purposes.
- Must sign an informed consent form agreeing to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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