Trials / Completed
CompletedNCT02973750
Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer
Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
- Ovarian Diseases
- Fallopian Tube Diseases
- Peritoneal Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Baseline Biopsy | Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures. |
| PROCEDURE | Tissue Collection | Tissue collection during debulking surgery. |
| PROCEDURE | Blood Draws | 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. |
Timeline
- Start date
- 2016-10-20
- Primary completion
- 2020-07-18
- Completion
- 2020-07-18
- First posted
- 2016-11-25
- Last updated
- 2023-01-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02973750. Inclusion in this directory is not an endorsement.