Brief Summary

This trial studies the 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. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

290

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

357 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed

2 months until next milestone

Study Start

First participant enrolled

August 15, 2011

Completed

10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed

Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

10.4 years

First QC Date

June 2, 2011

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days
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.
Up to 5 years
Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays
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.
Up to 5 years

Secondary Outcomes (5)

Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL
Baseline to up to 6 weeks after completion of course 4
Changes in comorbidity index measured by the Charlson scale
Baseline to up to 6 weeks after completion of course 4
Changes in nutritional status measured by weight
Baseline to up to 6 weeks after completion of course 4
Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer
Up to 5 years
Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events
Up to 6 weeks after course 4

Other Outcomes (1)

Pharmacokinetic parameters including paclitaxel AUC, carboplatin AUC, paclitaxel total body clearance, and time that plasma paclitaxel concentration remains above threshold 0.05 uM/L
Pre-dose, 1, 6, and 24 hours

Study Arms (1)

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 ComplicationsDrug: CarboplatinBiological: FilgrastimDrug: PaclitaxelOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Assessment of Therapy ComplicationsPROCEDURE

Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments