Clinical Trial: Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma

Brief Summary: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy

Detailed Summary:

OBJECTIVES:

I. Determine the activity of imatinib mesylate in patients with progressive, refractory, or recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based chemotherapy.

II. Determine the toxicity of this drug in this patient population. III. Determine KIT expression and identify mutations in the c-kit gene in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 32-38 months.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response rate defined as either a complete or partial response using RECIST criteria [ Time Frame: Up to 2 years ]

Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.


Original Primary Outcome:

Current Secondary Outcome:

  • Grade 1 or higher toxicities assessed using CTC)version 2 [ Time Frame: Up to 2 years ]
    Toxicities will be tabulated.
  • Duration of response [ Time Frame: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years ]
    The Kaplan-Meier product-limit method will be used.
  • Disease-free survival [ Time Frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years ]
    The Kaplan-Meier product-limit method will be used.
  • Overall survival [ Time Frame: From date of initiation of treatment to date of death due to any cause, assessed up to 2 years ]
    The Kaplan-Meier product-limit method will be used.
  • Proportion of patients with mutations in the c-KIT gene [ Time Frame: Up to 2 years ]
    The 95% confidence interval will be estimated.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 5, 2002
Date Started: June 2002
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013