Clinical Trial: AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the objective tumor response rate of AZD2171 administered to patients with recurrent or metastatic malignant melanoma.

II. To assess the toxicity, median survival time, 1-year survival rate, response or stable disease duration, time to disease progression and clinical benefit response of AZD2171 administered to patients with recurrent or metastatic malignant melanoma.

III. To measure baseline and post-treatment levels of angiogenic growth factors and receptors, as well as circulating endothelial cells, and to explore the relationship between these potential correlative endpoints and clinical outcome.

IV. To assess changes in blood flow and vessel permeability using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) pre- and post-treatment, and to explore the relationship between these potential imaging endpoints and clinical outcome.

V. To look for polymorphisms of kdr/flk-1, and other genes in this pathway, by performing pharmacogenetic analysis of pbmc's, and correlate genotype with VEGF levels and response to therapy.

OUTLINE: This is an open-label, multicenter study.

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

After completion of study treatment, patients are followed for survival.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective Tumor Response (Partial or Complete Response) According to RECIST [ Time Frame: Up to 6 years ]
    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."
  • Prolonged Stable Disease According to RECIST [ Time Frame: Up to 6 months ]


Original Primary Outcome:

Current Secondary Outcome:

  • Median Survival Time [ Time Frame: Up to 6 years ]
  • Survival Rate [ Time Frame: At 1 year ]
  • Response Duration [ Time Frame: 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 [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 6 years ]
  • Toxicity as Assessed by NCI CTCAE Version 3.0 [ Time Frame: Up to 6 years after completion of treatment ]
  • Time to Disease Progression [ Time Frame: Up to 6 years ]
  • Clinical Benefit Response [ Time Frame: Up to 6 years ]
  • Changes in Levels of Soluble Angiogenic Factors [ Time Frame: From baseline to up to 6 years ]
  • Change in Vessel Permeability and Blood Flow by DCE-MRI [ Time Frame: From baseline to up to 28 days after starting daily oral dosing ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 20, 2005
Date Started: January 2006
Date Completion:
Last Updated: June 1, 2015
Last Verified: May 2013