Clinical Trial: Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

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

Official Title: A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer

Brief Summary: This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.

II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.

SECONDARY OBJECTIVES:

I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis.

OUTLINE:

Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Progression free survival rate, defined as the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration [ Time Frame: 6 months ]
    A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval) if there are censored patients.
  • Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study [ Time Frame: Up to 3 years ]
    A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.


Original Primary Outcome:

  • Tumor response rate as assessed by RECIST criteria
  • 6-month progression-free survival rate


Current Secondary Outcome:

  • Duration of response [ Time Frame: Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years ]
    Median duration of response and the confidence interval for the median duration will be computed.
  • Incidence of adverse events, defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 3 years ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
  • Overall survival [ Time Frame: Time from registration to death, assessed up to 3 years ]
    Time to event distributions will be estimated using the Kaplan-Meier method.
  • Time to disease progression [ Time Frame: Time from registration to disease progression, assessed up to 3 years ]
  • Time to treatment failure [ Time Frame: Time from study entry to the date patients end treatment, assessed up to 3 years ]
    Time to treatment failure will be evaluated using the method of Kaplan-Meier.


Original Secondary Outcome:

  • Overall survival
  • Duration of response
  • Time to disease progression
  • Time to treatment failure


Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 6, 2009
Date Started: September 2009
Date Completion:
Last Updated: May 23, 2017
Last Verified: May 2017