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| Name | Class |
|---|---|
| The V Foundation for Cancer Research | OTHER |
| Kay Yow Cancer Fund | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Biopsy | Procedure | Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival (RFS) | 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Martine Extermann, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010049 | Ovarian Diseases |
| D005184 | Fallopian Tube Diseases |
| D010532 | Peritoneal Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D014015 | Tissue Banks |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D018070 | Biological Specimen Banks |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
| D013048 | Specimen Handling |
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Whole blood samples, Pharmacokinetic (PK) samples, Tumor tissue, Ascites.
| 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. |
|
| 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. | 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. | 6 months |
| Overall Survival (OS) |
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. |
| 12 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004066 | Digestive System Diseases |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |