Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Study of Sunitinib (SU11248; NSC 736511) an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given
orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or
metastatic carcinoma of the cervix.
II. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or
metastatic carcinoma of the cervix.
III. To document time to progression, early objective progression rate, and, if objective
responses are observed, response duration.
OUTLINE:
Patients receive sunitinib malate orally (PO) daily for 4 weeks. Treatment repeats every 6
weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving complete response (CR) or partial response (PR) may receive 2 courses
after CR or PR is reached.
After completion of study treatment, patients are followed up at 4 weeks and then every 3
months thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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