Know Cancer

forgot password

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

70 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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



- To determine whether the score on Instrumental Activities of Daily Living (IADL)
obtained at time of registration is associated with the ability of patients to complete
four courses of chemotherapy without dose reduction or a more than 7-day delay.

- To estimate by regimen the percentage of patients who are able to complete four courses
of chemotherapy regardless of dose reductions and delays.

- To compare actual and calculated carboplatin area under the curve (AUC) in this patient


- 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.

- 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).

- 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.

- To explore reasons for and timing of dose reductions and delays.

- To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores
on geriatric measures in this patient population.


- 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.

- To explore the association between baseline IADL and survival.

- 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 Functional Assessment of Cancer Therapy - Ovary
(FACT-O), the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale),
the Instrumental Activities of Daily Living (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


- 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), or paracentesis

- A diagnosis of a mucinous cancer must be made by biopsy only

- International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, or IV
are eligible

- Patients must have received no previous treatment for this malignancy other than

- Patient must be entered within eight weeks of confirmation of disease diagnosis by
surgery, biopsy, FNA or paracentesis, or within twelve weeks of primary or staging
surgery if patient received primary surgery

- Patient and physician agree that they plan to conduct treatment according to Regimen
1 or Regimen 2

- "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are


- GOG performance status of 0, 1, 2 or 3

- No GOG performance status of 4

- ANC ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Bilirubin normal

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Patients must be free of active infection requiring antibiotics

- Patient can read and understand sufficient English to be able to respond to questions
posed by the study instruments

- No patients with other invasive malignancies whose previous cancer treatment
contraindicates this protocol therapy

- No patients with medical conditions that in the opinion of the investigator render
treatment on this protocol unsafe

- Patients must have signed an approved informed consent and HIPAA

- In signing the consent, patients must agree to provide blood samples from which
plasma will be extracted to be tested for research purposes


- See Disease Characteristics

- Patients must have recovered from the effects of recent surgery

Type of Study:


Study Design:


Outcome Measure:

Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days

Safety Issue:


Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center



Study ID:




Start Date:

September 2011

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IA fallopian tube cancer
  • stage IB fallopian tube cancer
  • stage IC fallopian tube cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • stage IA ovarian epithelial cancer
  • stage IB ovarian epithelial cancer
  • stage IC ovarian epithelial cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IA primary peritoneal cavity cancer
  • stage IB primary peritoneal cavity cancer
  • stage IC primary peritoneal cavity cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sarasota Memorial Hospital Sarasota, Florida  34239
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53201-2901
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Long Island Jewish Medical Center New Hyde Park, New York  11040
Yale Cancer Center New Haven, Connecticut  06520-8028
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Lahey Clinic Medical Center - Burlington Burlington, Massachusetts  01805
St. Elizabeth Medical Center Edgewood, Kentucky  41017
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Maine Medical Center - Bramhall Campus Portland, Maine  04102
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Bismarck Cancer Center Bismarck, North Dakota  58501
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Palo Alto Medical Foundation Palo Alto, California  94301
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Praxair Cancer Center at Danbury Hospital Danbury, Connecticut  06810
Carl and Dorothy Bennett Cancer Center at Stamford Hospital Stamford, Connecticut  06904
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Grant Medical Center Cancer Care Columbus, Ohio  43215
Knox Community Hospital Mount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Vince Lombardi Cancer Clinic - Sheboygan Sheboygan, Wisconsin  53081
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Duke Cancer Institute Durham, North Carolina  27710
Rocky Mountain Gynecologic Oncology Englewood, Colorado  80110
Gynecologic Oncology Hinsdale, Illinois  60521
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Good Samaritan Hospital Cancer Treatment Center Cincinnati, Ohio  45220
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Alamance Cancer Center at Alamance Regional Medical Center Burlington, North Carolina  27216
Duke Health Raleigh Hospital Raleigh, North Carolina  27609
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Florida Gynecologic Oncology - Fort Myers Fort Myers, Florida  33905
Aurora Women's Pavilion of West Allis Memorial Hospital West Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Central Dupage Cancer Center Warrenville, Illinois  60555
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
St. Vincent Oncology Center Indianapolis, Indiana  46260
Mount Carmel Hospital East Columbus, Ohio  43215
Mercy Cancer Center - West Lakes Clive, Iowa  50325
Methodist West Hospital West Des Moines, Iowa  50266-7700
Zangmeister Center Columbus, Ohio  43219