Clinical Trial: Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

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

Official Title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Brief Summary: This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Detailed Summary:

OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.

II. Determine the nature and degree of toxicity of this drug in these patients.

Secondary I. Determine the partial and complete response rates in patients treated with this drug.

II. Determine the duration of PFS and overall survival of patients treated with this drug.

III. Determine the effect of this drug on initial performance status and histological grade in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and basic fibroblast growth factor, with clinical outcome (i.e., PFS) in patients treated with this drug.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.


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 lesion for measurable disease every other cycle ]
    Whether or not the patient survived progression-free for at least 6 months.
  • Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 [ Time Frame: Up to 5 years ]


Original Primary Outcome:

Current Secondary Outcome:

  • Progression Free Survival [ 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 lesion for measurable disease every other cycle ]
  • 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 lesion for measurable disease every other cycle. ]
    Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (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.
  • Initial Performance Status and Histological Grade [ Time Frame: Up to 5 years ]
  • Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF [ Time Frame: Up to 5 years ]
  • Serum and Plasma Concentrations of VEGF and bFGF With PFS [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 11, 2001
Date Started: September 2001
Date Completion:
Last Updated: May 7, 2015
Last Verified: December 2013