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 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 IIIA Fallopian Tube Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage I Ovarian Cancer AJCC v6 and 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
Conditions
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.
Detailed description
PRIMARY OBJECTIVES: l. To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained prior to treatment is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7-day delay. II. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays. III. To compare actual and calculated carboplatin area under the curve (AUC) in this patient population. SECONDARY OBJECTIVES: I. To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group. II. To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients). III. To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay. IV. To explore reasons for and timing of dose reductions and delays. V. To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population. TERTIARY OBJECTIVES: I. To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment. II. To explore the association between baseline IADL and survival. III. To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy ? Ovary (FACT-O). OUTLINE: 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 Functional Assessment of Cancer Treatment ? Neurotoxicity (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.
Interventions
PROCEDUREAssessment of Therapy Complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
DRUGCarboplatin
Undergo chemotherapy
BIOLOGICALFilgrastim
Undergo chemotherapy
DRUGPaclitaxel
Undergo chemotherapy
OTHERPharmacological Study
Correlative studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only * International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible * Patients must have received no previous treatment for this malignancy other than surgery * Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl * Platelets greater than or equal to 100,000/mcl * Bilirubin less than or equal upper limit of normal (ULN) * Creatinine less than or equal to 1.5 x ULN * Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3 * Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013) * Patients must have recovered from the effects of recent surgery * Patients must be free of active infection requiring antibiotics * Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) * Patient and physician agree that they plan to conduct treatment according to Regimen 3 * Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments
Exclusion criteria
* Patients who have received previous treatment for this malignancy other than surgery * Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy * ?Borderline tumors? (tumors of low malignant potential) by surgery or biopsy are excluded * Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays | 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. |
| Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment. |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed