Clinical trial NCT02973750: Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer
Official title: Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Ovarian Diseases
Fallopian Tube Diseases
Peritoneal Diseases
Keywords: high-grade serous cancer
stage III cancer
stage IV cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: The V Foundation for Cancer Research
name: Kay Yow Cancer Fund
First posted: 2016-11-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of Skeletal Muscle Index and Fat Index With AUC
timeFrame: 6 months
measure: Correlation of Skeletal Muscle Index, Fat Index and AUC with Toxicity
timeFrame: 6 months
measure: Association of Age With Changes
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of Age With Gene Expression Changes
timeFrame: 6 months
measure: Impact of Inflammation on Gene Expression and Response
timeFrame: 6 months
measure: Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI)
timeFrame: 6 months
Other outcomes:
measure: Relapse Free Survival (RFS)
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 12 months
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Martine Extermann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: