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:3/14/2019
Start Date:August 15, 2011

Use our guide to learn which trials are right for you!

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
358
sites
Knoxville, Tennessee 37996
(865) 974-1000
University of Tennessee - Knoxville Founded in 1794, we're big on tradition and proud of...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
?
mi
from
Augusta, ME
Click here to add this to my saved trials
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...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33901
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
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...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
1 Akron General Avenue
Akron, Ohio 44307
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Baton Rouge, Louisiana 70815
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beech Grove, Indiana 46107
?
mi
from
Beech Grove, IN
Click here to add this to my saved trials
800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
?
mi
from
Belpre, OH
Click here to add this to my saved trials
Bemidji, Minnesota 56601
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boone, Iowa 50036
?
mi
from
Boone, IA
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burlington, Massachusetts 01805
?
mi
from
Burlington, MA
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
?
mi
from
Canton, OH
Click here to add this to my saved trials
6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
?
mi
from
Casper, WY
Click here to add this to my saved trials
Cedar Rapids, Iowa 52403
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60640
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
?
mi
from
Chillicothe, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Mercy Cancer Center - West Lakes When it comes to cancer care, there
?
mi
from
Clive, IA
Click here to add this to my saved trials
?
mi
from
Clive, IA
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43222
?
mi
from
Columbus, OH
Click here to add this to my saved trials
810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45415
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dearborn, Michigan 48124
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
?
mi
from
Delaware, OH
Click here to add this to my saved trials
Delaware, Ohio 43015
?
mi
from
Delaware, OH
Click here to add this to my saved trials
561 West Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Delaware Health Center-Grady Cancer Center As the center of healthcare in Delaware County, Grady Memorial...
?
mi
from
Delaware, OH
Click here to add this to my saved trials
1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials