Clinical Trial: Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology

Brief Summary:

While significant progress has been made in the treatment and prognosis of ovarian cancer, this progress has mostly shown benefits for younger women.

This study aims to understand two things: How body composition (the amount of muscle and water versus fat in in the body) affects the dose and side effects of chemotherapy; and the biological reason for the worse prognosis with aging. To get a good view of these effects, investigators are asking the help of both younger and older women for this project.

Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome:

• Correlation of Skeletal Muscle Index and Fat Index With AUC [ Time Frame: 6 months ]
  Assess the correlation of skeletal muscle index and fat index with the AUC of carboplatin and paclitaxel. Pearson's correlation tests will be performed to assess the correlation of skeletal muscle index and fat index with the AUC of carboplatin and paclitaxel.
• Correlation of Skeletal Muscle Index, Fat Index and AUC with Toxicity [ Time Frame: 6 months ]
  Correlate skeletal muscle index, fat index, and AUC with toxicity from preoperative chemotherapy (CTCAE 4.0), nadir neutrophil counts, and relative dose-intensity (RDI). Pearson's correlation tests will be performed to assess skeletal muscle index, fat index, and AUC with toxicity from preoperative chemotherapy, nadir neutrophil counts, and relative dose-intensity (RDI).
• Association of Age With Changes [ Time Frame: 6 months ]
  Assess the association of age with changes in mean values, variance, or strength or correlation under 1A and 1B. Unpaired t-tests, Mann-Whitney tests and ANOVA tests will be performed to assess the differences between young (<70) and old (>=70) patients in means, medians and variances of body composition, AUC, toxicity from preoperative chemotherapy, nadir neutrophil counts and RDI.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Correlation of Age With Gene Expression Changes [ Time Frame: 6 months ]
  Assess the correlation with age of gene expression changes in the tumor and its micro-environment before and after neoadjuvant chemotherapy and its correlation with tumor response. Pearson's correlation tests will be performed on age vs. gene expressions, micro-environment and tumor responses before and after neoadjuvant chemotherapy. Paired t-tests will be performed to assess gene expression changes in tumor and its micro-environment before and after neoadjuvant chemotherapy.
• Impact of Inflammation on Gene Expression and Response [ Time Frame: 6 months ]
  Assess the impact of inflammation, as assessed by serum and ascites cytokines on gene expression and response, and its correlation with age. Pearson's correlation tests will be performed to assess the impact of inflammation, as assessed by serum and ascites cytokines on gene expression and response, and its correlation with age.
• Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI) [ Time Frame: 6 months ]
  Assess the impact of inflammation on toxicity and RDI. Pearson's correlation tests will be performed to assess the impact of inflammation on toxicity and RDI.

Original Secondary Outcome: Same as current

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: November 22, 2016
Date Started: August 31, 2016
Date Completion: December 2018
Last Updated: April 27, 2017
Last Verified: April 2017