AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma (NCT00243061) | Clinical Trial Compass
CompletedPhase 2
AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma
Canada24 participantsStarted 2006-01
Plain-language summary
This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
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:
* Histologically/cytologically confirmed recurrent/metastatic malignant melanoma (stage IV acral lentiginous, lentigo maligna, superficial spreading or ocular malignant melanoma)
* Measurable disease- at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as \>=20mm with conventional techniques or \>=10mm with spiral CT scan
* Previously irradiated lesions not considered measurable unless they demonstrated progression prior to study entry
* No prior chemotherapy (including regional therapy); prior adjuvant immunotherapy permitted if completed \>3 months prior to study entry; patients may have received prior radiation therapy if completed \>=4 weeks prior to study entry
* Previous surgery permissible if performed \>=4 weeks prior to study entry
* Life expectancy \>12 weeks
* ECOG performance status=\< 2 (Karnofsky\>=60%)
* Leukocytes\>=3,000/mcL
* Absolute neutrophil count\>=1,500/mcL
* Platelets\>=100,000/mcL
* Hemoglobin\>=8g/dL
* Total bilirubin\<1.5x institutional ULN (IULN)
* AST/ALT=\<3 x IULN (5xULN if liver metastases)
* Creatinine within IULN
* Creatinine within IULN OR
* Creatinine clearance\>=60mL/min/m\^2 if creatinine levels above IULN
* Baseline blood pressure \<140/90mmHg; may be taking antihypertensive medications
* AZD2171 has shown to terminate fetal development in rat as expected for process dependent on VEGF signaling; women of childbearing potential must have negative pregnancy test prior to study entry;…
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.
What they're measuring
1
Objective Tumor Response (Partial or Complete Response) According to RECIST