Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2016
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2020
CompletedJanuary 26, 2023
January 1, 2023
3.7 years
November 22, 2016
January 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Correlation of Skeletal Muscle Index and Fat Index With AUC
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.
6 months
Correlation of Skeletal Muscle Index, Fat Index and AUC with Toxicity
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).
6 months
Association of Age With Changes
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.
6 months
Secondary Outcomes (3)
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
Other Outcomes (2)
Relapse Free Survival (RFS)
12 months
Overall Survival (OS)
12 months
Study Arms (1)
Pre-Surgery Chemotherapy Patients
All participants. Patients receiving chemotherapy with carboplatin and paclitaxel before their debulking surgery, who may have more chemotherapy after surgery. Sampling procedures will include: Baseline Biopsy; Tissue Collection; Blood Draws.
Interventions
Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures.
Tissue collection during debulking surgery.
Blood samples for paclitaxel and carboplatin plasma levels will be collected in the study. Paclitaxel will be measured on cycle 1 day 1 at predose and then at the end of the infusion, followed by 1, 2, 4, 8 hours after the end of infusion, then on cycle 1 day 2 at 24 hours after the end of infusion. Carboplatin will be sampled for on cycle 1 day 1 at predose and then at the end of the infusion, followed by 0.5, 1.5, 3.5, 7.5 hours after the end of infusion, then on cycle 1 day 2 at 23.5 hours after the end of infusion.
Eligibility Criteria
Female cancer patients age 18 years or older, with at least one third of the participants to be aged 70 years or more. Participants must have high-grade serous ovarian, fallopian, or peritoneal cancer, stage III or IV. Women and members of all races and ethnic groups are eligible for this trial. The study is not relevant to men. With a sample of 50 patients, investigators can detect a correlation as strong as 0.38 between body composition and AUC of carboplatin and paclitaxel with a power of 0.80 at the significance level of 0.05. In order to allow for a 10% drop out/incompletion rate, investigators will accrue 55 participants.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- The V Foundation for Cancer Researchcollaborator
- Kay Yow Cancer Fundcollaborator
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Links
Biospecimen
Whole blood samples, Pharmacokinetic (PK) samples, Tumor tissue, Ascites.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine Extermann, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 25, 2016
Study Start
October 20, 2016
Primary Completion
July 18, 2020
Study Completion
July 18, 2020
Last Updated
January 26, 2023
Record last verified: 2023-01