Clinical Trial: Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

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

Official Title: A Phase II Evaluation of Gleevec(TM) (NCI-Supplied Agent: STI571 [Imatinib Mesylate], NSC# 716051) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Brief Summary: This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the activity of Gleevec^trademark (TM) (imatinib mesylate) as measured by progression-free survival at six months.

II. To determine the frequency and severity of adverse effects of Gleevec^TM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events version 3.0 (CTCAE v3.0).

SECONDARY OBJECTIVES:

I. To determine the distribution of progression-free survival and overall survival.

II. To estimate the objective response rate (partial and complete response as defined under the Response Evaluation Criteria In Solid Tumors [RECIST] criteria).

III. To determine the effects of prognostic factors such as initial performance status and histological grade.

TERTIARY OBJECTIVES:

I. To determine the levels of expression of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (c-KIT), platelet-derived growth factor receptor (PDGFR), v-akt murine thymoma viral oncogene homolog 2 (AKT2), and phosphorylated (p)-AKT2 in archived, formalin-fixed, paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy

OUTLINE:

Patients receive imatinib mesylate orally (PO) once daily (QD) or twice daily (BID) 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 up every 3 months for 2 years a
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

• Progression-free Survival (PFS) > 6 Months [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter. ]
  Whether or not the patient survived progression-free for at least 6 months.
• Incidence of Adverse Effects as Assessed by CTCAE v 3.0 [ Time Frame: Up to 5 years ]
  The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.

Original Primary Outcome:

Current Secondary Outcome:

• Tumor Response [ Time Frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter. ]
  Complete and Partial Tumor Response by RECIST 1.0
• Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years. ]
  The observed length of life from entry into the study to death or the date of last contact
• Duration of PFS [ Time Frame: Up to 5 years ]
• Initial Performance Status [ Time Frame: Baseline ]
  Assessed as a prognostic factor.
• Initial Histologic Grade [ Time Frame: Baseline ]
  Assessed as a prognostic factor.
• c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC) [ Time Frame: Baseline ]
  Potential associations with clinical or PFS response will be assessed.
• PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC [ Time Frame: Baseline ]
  Potential associations with clinical or PFS response will be assessed.
• AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC [ Time Frame: Baseline ]
  Potential associations with clinical or PFS response will be assessed.
• p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue [ Time Frame: Baseline ]
  Potential associations with clinical or PFS response will be assessed.

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 9, 2004
Date Started: January 2004
Date Completion:
Last Updated: May 6, 2015
Last Verified: March 2014