Ovarian CancerNCT02973750
Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Baseline Biopsy, Tissue Collection and Blood Draws
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2016to 18 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology
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
- Being tested
- Baseline Biopsy, Tissue Collection, Blood Draws
- Keywords
- high-grade serous cancer, stage III cancer, stage IV cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Ovarian Diseases, Fallopian Tube Diseases, Peritoneal Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline BiopsyProcedure or surgery
Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures.
Tissue CollectionProcedure or surgery
Tissue collection during debulking surgery.
Blood DrawsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Surgery Chemotherapy Patients | 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. Receives: Procedure: Baseline Biopsy; Procedure: Tissue Collection; Procedure: Blood Draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Skeletal Muscle Index and Fat Index With AUC
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.
Measured: 6 months
Correlation of Skeletal Muscle Index, Fat Index and AUC with Toxicity
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).
Measured: 6 months
Association of Age With Changes
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.
Measured: 6 months
Secondary outcomes (3)
Correlation of Age With Gene Expression Changes
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.
Measured: 6 months
Impact of Inflammation on Gene Expression and Response
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.
Measured: 6 months
Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start20 Oct 2016
- Primary completion18 Jul 2020
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation for Cancer Research, Kay Yow Cancer Fund
- Responsible party
- Sponsor
- Investigators
- Martine Extermann, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973750
- Sponsor's protocol ID
- MCC-18682
- Status last verified
- Jan 2023
- First submitted
- 22 Nov 2016
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer: Prospective Study of Pharmacokinetics Patterns and Underlying Biology
- ClinicalTrials.gov ID
- NCT02973750
- Acronym / sponsor ID
- MCC-18682
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- The V Foundation for Cancer Research, Kay Yow Cancer Fund
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgery Chemotherapy Patients | – | Procedure: Baseline Biopsy, Procedure: Tissue Collection, Procedure: Blood DrawsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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%).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline BiopsyBaseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures. | Procedure or surgery | Pre-Surgery Chemotherapy Patients |
| Tissue CollectionTissue collection during debulking surgery. | Procedure or surgery | Pre-Surgery Chemotherapy Patients |
| Blood DrawsBlood 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. | Procedure or surgery | Pre-Surgery Chemotherapy Patients |
Primary outcome
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.
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).
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.
3 secondary outcomes
Correlation of Age With Gene Expression Changes
Time frame: 6 months
Impact of Inflammation on Gene Expression and Response
Time frame: 6 months
Impact of Inflammation on Toxicity and Relative Dose-Intensity (RDI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Extermann, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Skeletal Muscle Index and Fat Index With AUC (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.