Bevacizumab vs Dacarbazine in Metastatic Melanoma (NCT01705392) | Clinical Trial Compass
TerminatedPhase 2
Bevacizumab vs Dacarbazine in Metastatic Melanoma
Stopped: Lack of financing of the study drug. Not sufficient financial support.
Norway2 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to evaluate the predictive value of a set biomarkers associated with vascular endothelial growth factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic growth factors than VEGF. Finally, we want to analyze safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers in comparison with an ACE inhibitor.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Previously treated or untreated, histologically confirmed, metastatic and unresectable melanoma with progressive disease
* Both BRAF wild type patients as well as BRAF mutated patients are allowed. For BRAF mutated patients, BRAF targeting agents should be considered in first line if otherwise indicated and no contraindications exist.
* WHO performance status 0-1
* Age \>18 years,
* Known BRAF mutation
* Able to undergo outpatient treatment
* Patients must have clinically and/or radiographically documented measurable disease according to RECIST.
* All radiology studies must be performed within 28 days prior to registration (35 days if negative).
* At least 4 weeks since adjuvant interferon alpha
* At least 4 weeks since 1st line treatment in case of metastasis
* Major surgical procedure or significant traumatic injury \> 28 days prior to study treatment start. Biopsy or fine needle aspiration \> 2 days prior to study treatment start. Central venous line placement must be inserted at least 2 days prior to treatment start.
* Only patients with irradiated and asymptomatic brain metastases and off dexamethasone are allowed.
* Hematology: absolute granulocytes \> 1.0 x 109/L
* Platelets \> 100 x 109/L
* Bilirubin \< 1.5 x upper normal limit
* Serum creatinine \< 1.5 x upper normal limits
* LDH \< 1.5 x upper normal limit
* INR \< 1.5
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the stu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.