Brief Title
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
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 Type
Observational
Primary Outcome
Correlation of Skeletal Muscle Index and Fat Index With AUC
Secondary Outcome
Correlation of Age With Gene Expression Changes
Condition
Ovarian Cancer
Intervention
Baseline Biopsy
Study Arms / Comparison Groups
Pre-Surgery Chemotherapy Patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
20
Start Date
August 31, 2016
Completion Date
January 2021
Primary Completion Date
January 2021
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Martine Extermann, M.D., Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02973750
Organization ID
MCC-18682
Responsible Party
Sponsor
Study Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
The V Foundation for Cancer Research
Study Sponsor
Martine Extermann, M.D., Ph.D., Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute
Verification Date
July 2020