test

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

Conditions

Stage I Ovarian Epithelial Cancer | Stage I Primary Peritoneal Cavity Cancer | Stage IA Fallopian Tube Cancer | Stage IB Fallopian Tube Cancer | Stage IC Fallopian Tube Cancer | Stage II Ovarian Epithelial Cancer | Stage II Primary Peritoneal Cavity Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage III Ovarian Epithelial Cancer | Stage III Primary Peritoneal Cavity Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIC Fallopian Tube Cancer | Stage IV Fallopian Tube Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Primary Peritoneal Cavity Cancer

Trial Phase

N/A

Trial Purpose and Description

Trial Purpose

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 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.

Participation Guidelines

Age:
75 Years - N/A
Gender:
Both

Eligibility Criteria


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
Sponsor:
Gynecologic Oncology Group
National Cancer Institute (NCI)
Dates:
August 2011
Last Updated:
August 8, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT01366183