Clinical Trial 18682

Cancer Type: Gynecological Tumor
Interventions:Paraplatin (carboplatin); Taxol (paclitaxel); carboplatin; paclitaxel

Study Type: Other
Phase of Study: NA
Investigators:

  • Martine Extermann

Overview

Study Title

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

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.

Objective

Primary: A.) Assess the correlation of body composition with the AUC of carboplatin and paclitaxel. B.) Correlate body composition and AUC with toxicity from preoperative chemotherapy (CTCAE 4.0), nadir neutrophil counts, and relative dose-intensity (RDI). C.) Assess the association of age with changes in mean values, variance, or strength or correlation under 1A and 1B. Secondary: A.) 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. B.) Assess the impact of inflammation, as assessed by serum and ascites cytokines on gene expression and response, and its correlation with age. C.) Assess the impact of inflammation on toxicity and RDI. D.) Correlate the above parameters with relapse-free survival (RFS), and overall survival (OS).

Inclusion Criteria

  • Participants must have one of the following: a) Histological or cytological diagnosis of high-grade serous ovarian, fallopian, or peritoneal cancer, stage III or IV; b) In the opinion of investigator, highly suspicious stage III or IV ovarian, fallopian, or peritoneal cancer (histologically confirmed non-serous ovarian, fallopian, and peritoneal cancers will be considered screening failures).
  • At least one biopsiable lesion by CT/US or laparoscopy.
  • Have not received previous treatment for ovarian cancer.
  • Age >= 18 years (At least one third of the patients will be required to be aged 70 years or more).
  • Life expectancy of greater than 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status 60%).
  • Must have adequate organ and marrow function.
  • Deemed eligible for neo-adjuvant chemotherapy with carboplatin and paclitaxel and surgery by their oncologist.
  • Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.

  • Exclusion Criteria

  • Active second malignancy within last 2 years (except non-melanoma skin cancer or in situ carcinomas.
  • Prior treatment for ovarian cancer.
  • Potential participants with known brain metastases will be excluded from this clinical trial.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin and paclitaxel.
  • Known allergy to carboplatin, paclitaxel, or cremophor.
  • Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant. Breastfeeding should be discontinued if the mother is treated with carboplatin and paclitaxel. These potential risks may also apply to other agents used in this study.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin and paclitaxel or other agents administered during the study.