Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT01366183|
Recruitment Status : Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment|
|Stage I Ovarian Cancer AJCC v6 and v7 Stage IA Fallopian Tube Cancer AJCC v6 and v7 Stage IB Fallopian Tube Cancer AJCC v6 and v7 Stage IC Fallopian Tube Cancer AJCC v6 and v7 Stage II Ovarian Cancer AJCC v6 and v7 Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIB Fallopian Tube Cancer AJCC v6 and v7 Stage IIC Fallopian Tube Cancer AJCC v6 and v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7||Procedure: Assessment of Therapy Complications Drug: Carboplatin Biological: Filgrastim Drug: Paclitaxel Other: Pharmacological Study Other: Quality-of-Life Assessment Other: Questionnaire Administration|
|Study Type :||Observational|
|Estimated Enrollment :||290 participants|
|Official Title:||Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
|Actual Study Start Date :||August 15, 2011|
|Estimated Primary Completion Date :||December 31, 2021|
Observational (quality of life questionnaire)
Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.
Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.
Procedure: Assessment of Therapy Complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days [ Time Frame: Up to 5 years ]Will be modeled with logistic regression using baseline IADL scores as a covariate. Exploratory analysis will evaluate baseline IADL scores adjusting for covariates such as: Charlson scale, nutritional status, or age.
- Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays [ Time Frame: Up to 5 years ]While this percentage will be estimated for each study regimen separately, the targeted sample size will limit the width of the 95%-confidence interval for the marginal percentage so that it is no larger than 0.15.
- Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]The changes in FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL will be summarized descriptively as the differences of scores between pre and post chemotherapy. Assuming 80% of patients complete the assessment at the completion of chemotherapy, then a sample of 148 patients will provide 90% power to detect 5 unit changes in FACT-O, 0.5 unit change in FACT/GOG-Ntx subscale score, 1 unit change in IADL or ADL score using paired t-test at significant level of 0.05.
- Changes in comorbidity index measured by the Charlson scale [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]
- Changes in nutritional status measured by weight [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]The changes in weight will be summarized descriptively as the differences of scores between pre and post chemotherapy. The change of nutritional status after completing chemotherapy will be examined using McNemar?s test.
- Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer [ Time Frame: Up to 5 years ]
- Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events [ Time Frame: Up to 6 weeks after course 4 ]The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment.
- Pharmacokinetic parameters including paclitaxel AUC, carboplatin AUC, paclitaxel total body clearance, and time that plasma paclitaxel concentration remains above threshold 0.05 uM/L [ Time Frame: Pre-dose, 1, 6, and 24 hours ]The observed pharmacokinetics of paclitaxel and carboplatin will be compared with published pharmacokinetic measures of paclitaxel and carboplatin in a descriptive fashion. No formal statistical testing will be performed for the comparisons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366183
|Principal Investigator:||Vivian E von Gruenigen||Gynecologic Oncology Group|