Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Correlation of Skeletal Muscle Index and Fat Index With AUC
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •Life expectancy of greater than 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status <3 (Karnofsky >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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Correlation of Age With Gene Expression Changes(6 months)
- Impact of Inflammation on Gene Expression and Response(6 months)
- Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI)(6 months)