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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:75 - Any
Updated:4/21/2016
Start Date:August 2011

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Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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.

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.

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
We found this trial at
361
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
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Jupiter, Florida 33458
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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524 South Park Street
Kalamazoo, Michigan 49007
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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300 Community Drive
Manhasset, New York 11030
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
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1 Akron General Ave
Akron, Ohio 44307
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Albany, New York 12208
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Albuquerque, New Mexico 87106
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1111 Duff Ave
Ames, Iowa 50010
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22 South Greene Street
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6701 N Charles St
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489 State St
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800 Farson Street
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300 N. Seventh St.
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
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400 South Clark Street
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2600 Sixth St. SW
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6501 E 2nd St
Casper, Wyoming 82609
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505 S Plummer Ave
Chanute, Kansas 66720
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Chapel Hill, North Carolina 27599
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5841 S Maryland Ave
Chicago, Illinois 60637
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272 Hospital Rd
Chillicothe, Ohio 45601
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2500 Metrohealth Dr
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12495 University Ave
Clive, Iowa 50325
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1831 Fifth Avenue
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810 Jasonway Avenue
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3535 Olentangy River Rd
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3100 Plaza Properties Blvd
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111 S Grant Ave
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1111 6th Ave
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