AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma

NCT00243061 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-03026PHL-038N01CM62203N01CM62201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acral Lentiginous Malignant Melanoma; Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Extraocular Extension Melanoma; Intraocular Melanoma; Iris Melanoma; Lentigo Maligna Malignant Melanoma; Recurrent Melanoma; Stage, Intraocular Melanoma; Stage IV Melanoma; Superficial Spreading Malignant Melanoma

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response (Partial or Complete Response) According to RECIST

  Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[J Nat Cancer Inst 92(3):205-216, 2000\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

  Up to 6 years

• Prolonged Stable Disease According to RECIST

  Up to 6 months

Secondary Outcomes (9)

• Median Survival Time

  Up to 6 years

• Survival Rate

  At 1 year

• Response Duration

  From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years

• Stable Disease Duration

  From the start of the treatment until the criteria for progression are met, assessed up to 6 years

• Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0

  Up to 6 years after completion of treatment

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: cediranib maleate

Interventions

cediranib maleate DRUG

Given orally

Also known as: AZD2171

Treatment (cediranib maleate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any previous chemotherapy or immunotherapy for recurrent/metastatic disease; patients who have had radiotherapy or major surgery within 4 weeks prior to entering study or those who have not recovered from AEs due to treatment received more than 4 weeks earlier
• May not be concurrently receiving other investigational agents nor have participated in an investigational trial of bio-, chemo- or immunotherapy agents
• Known brain metastases because of their poor prognosis and because patients often develop progressive neurologic dysfunction that would confound evaluation of neurologic and other AEs
• History of allergic reactions attributed to compounds of similar chemical/biologic composition to AZD2171
• Mean QTc\>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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Elaine McWhirter
• Organization: Juravinski Cancer Centre

elaine.mcwhirter@hrcc.on.ca

905-387-9495

Study Officials

• Elaine McWhirter

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 27, 2018
• Results First Posted: June 23, 2015

Record last verified: 2018-07

Locations

CA (1)