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 range18 Years
SexALL
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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;…
What they're measuring
1
Objective Tumor Response (Partial or Complete Response) According to RECIST