Overview

This trial is active, not recruiting.

Conditions stage i ovarian cancer, stage ia fallopian tube cancer, stage ib fallopian tube cancer, stage ic fallopian tube cancer, stage ii ovarian cancer, stage iia fallopian tube cancer, stage iib fallopian tube cancer, stage iic fallopian tube cancer, stage iii ovarian cancer, stage iii primary peritoneal cancer, stage iiia fallopian tube cancer, stage iiib fallopian tube cancer, stage iiic fallopian tube cancer, stage iv fallopian tube cancer, stage iv ovarian cancer, stage iv primary peritoneal cancer
Treatments assessment of therapy complications, carboplatin, filgrastim, paclitaxel, pharmacological study, quality-of-life assessment, questionnaire administration
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date August 2011
End date December 2019
Trial size 290 participants
Trial identifier NCT01366183, GOG-0273, NCI-2011-02900, U10CA101165

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
assessment of therapy complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
carboplatin Blastocarb
Undergo chemotherapy
filgrastim Filgrastim XM02
Undergo chemotherapy
paclitaxel Anzatax
Undergo chemotherapy
pharmacological study
Correlative studies
quality-of-life assessment Quality of Life Assessment
Ancillary studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants at least 75 years old.

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

Additional Information

Official title Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Principal investigator Vivian von Gruenigen
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.