Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

NCT02973750 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-01-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The V Foundation for Cancer Research

    collaborator OTHER
  • Kay Yow Cancer Fund

    collaborator UNKNOWN
  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Martine Extermann, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2020-07-18
Completion
2020-07-18

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02973750 on ClinicalTrials.gov