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NCT Number: NCT02973750

Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Digestive System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Peritoneal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline Biopsy

Procedure

Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures.

Tissue collection

Procedure

Tissue collection during debulking surgery.

Blood draws

Procedure

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.

Primary outcomes

  1. Correlation of Skeletal Muscle Index and Fat Index With AUC

    Time frame: 6 months

    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.

  2. Correlation of Skeletal Muscle Index, Fat Index and AUC with Toxicity

    Time frame: 6 months

    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).

  3. Association of Age With Changes

    Time frame: 6 months

    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.

Secondary outcomes

  1. Correlation of Age With Gene Expression Changes

    Time frame: 6 months

    Assess the correlation with age of gene expression changes in the tumor and its micro-environment before and after neoadjuvant chemotherapy and its correlation with tumor response. Pearson's correlation tests will be performed on age vs. gene expressions, micro-environment and tumor responses before and after neoadjuvant chemotherapy. Paired t-tests will be performed to assess gene expression changes in tumor and its micro-environment before and after neoadjuvant chemotherapy.

  2. Impact of Inflammation on Gene Expression and Response

    Time frame: 6 months

    Assess the impact of inflammation, as assessed by serum and ascites cytokines on gene expression and response, and its correlation with age. Pearson's correlation tests will be performed to assess the impact of inflammation, as assessed by serum and ascites cytokines on gene expression and response, and its correlation with age.

  3. Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI)

    Time frame: 6 months

    Assess the impact of inflammation on toxicity and RDI. Pearson's correlation tests will be performed to assess the impact of inflammation on toxicity and RDI.

Other outcomes

  1. Relapse Free Survival (RFS)

    Time frame: 12 months

    Correlate the primary and secondary parameters with RFS. Multivariate survival tests using Cox Proportional Hazard model and log-rank tests will be performed to assess the above parameters with relapse-free survival. Given the observational nature of this study, no Bonferroni adjustment is planned.

  2. Overall Survival (OS)

    Time frame: 12 months

    Correlate the primary and secondary parameters with OS. Multivariate survival tests using Cox Proportional Hazard model and log-rank tests will be performed to assess the above parameters with overall survival. Given the observational nature of this study, no Bonferroni adjustment is planned.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Kay Yow Cancer Fund
  • The V Foundation for Cancer Research

Registry information

Official study title

Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2016
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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