Phase 2
N=24
AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma
Acral Lentiginous Malignant Melanoma · Ciliary Body and Choroid Melanoma, Medium/Large Size · Ciliary Body and Choroid Melanoma, Small Size · Extraocular Extension Melanoma · Intraocular Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00243061 ↗Enrolled (actual)
24
Serious AEs
37.5%
Results posted
Jun 2015
Primary outcome: Primary: Objective Tumor Response (Partial or Complete Response) According to RECIST — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cediranib maleate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response (Partial or Complete Response) According to RECIST |
— | — |
| PRIMARY Prolonged Stable Disease According to RECIST |
9 | — |
| SECONDARY Median Survival Time |
9.9 | — |
| SECONDARY Survival Rate |
41 | — |
| SECONDARY Response Duration |
— | — |
| SECONDARY Stable Disease Duration |
4.6 | — |
| SECONDARY Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0 |
4 | — |
| SECONDARY Time to Disease Progression |
4.1 | — |
| SECONDARY Clinical Benefit Response |
— | — |
| SECONDARY Changes in Levels of Soluble Angiogenic Factors |
— | — |
| SECONDARY Change in Vessel Permeability and Blood Flow by DCE-MRI |
— | — |
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.
Eligibility Criteria
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= =60%)
- Leukocytes>=3,000/mcL
- Absolute neutrophil count>=1,500/mcL
- Platelets>=100,000/mcL
- Hemoglobin>=8g/dL
- Total bilirubin =60mL/min/m^2 if creatinine levels above IULN
- Baseline blood pressure 470msec (Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
- >+1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart
- Uncontrolled intercurrent illness including but not limited to hypertension, ongoing/active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women excluded from study because AZD2171 is a VEGF inhibitor with known abortifacient effects; breastfeeding should be discontinued if mother is treated with AZD2171
- HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for PK interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
- Any significant abnormality noted in ECG within 14 days of treatment
- A NYHA classification of III or IV (NOTE: Patients classified as class II controlled with treatment may continue with increase monitoring)
- Conditions requiring concurrent use of drugs/biologics with proarrhythmic potential; these drugs are prohibited during studies with AZD2171
Data sourced from ClinicalTrials.gov (NCT00243061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.