Clinical Trial: Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary

Brief Summary: This phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease.

SECONDARY OBJECTIVES:

I. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients.

TERTIARY OBJECTIVES:

I. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Tumor Response [ Time Frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels ]

Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0


Original Primary Outcome: Tumor response rate (complete and partial response)

Current Secondary Outcome:

  • Progression-free Survival [ Time Frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels ]
    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
  • 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.
  • Frequency and Severity of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Overall Survival
  • Progression-free Survival
  • Expression of angiogenic or lymphangiogenic markers (i.e., VEGF ligand, receptor, and activated receptor; EGF ligand, receptor, and activated receptor; β-catenin; LYVE-1 [lymphatic marker]; IL-8; ER-alpha; ER-beta; and androgen receptor)


Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 5, 2008
Date Started: September 2008
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017