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


N/A
70 Years
N/A
Open (Enrolling)
Both
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


OBJECTIVES:

Primary

- 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
population.

Secondary

- 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.

Tertiary

- 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


DISEASE CHARACTERISTICS:

- 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
surgery

- 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
excluded

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Patients must have recovered from the effects of recent surgery

Type of Study:

Observational

Study Design:

N/A

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:

Yes

Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000701177

NCT ID:

NCT01366183

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sarasota Memorial HospitalSarasota, Florida  34239
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Bismarck Cancer CenterBismarck, North Dakota  58501
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Palo Alto Medical FoundationPalo Alto, California  94301
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Praxair Cancer Center at Danbury HospitalDanbury, Connecticut  06810
Carl and Dorothy Bennett Cancer Center at Stamford HospitalStamford, Connecticut  06904
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Grant Medical Center Cancer CareColumbus, Ohio  43215
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Vince Lombardi Cancer Clinic - SheboyganSheboygan, Wisconsin  53081
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Duke Cancer InstituteDurham, North Carolina  27710
Rocky Mountain Gynecologic OncologyEnglewood, Colorado  80110
Gynecologic OncologyHinsdale, Illinois  60521
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Duke Health Raleigh HospitalRaleigh, North Carolina  27609
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Florida Gynecologic Oncology - Fort MyersFort Myers, Florida  33905
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - OshkoshOshkosh, Wisconsin  54904
Central Dupage Cancer CenterWarrenville, Illinois  60555
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
St. Vincent Oncology CenterIndianapolis, Indiana  46260
Mount Carmel Hospital EastColumbus, Ohio  43215
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Zangmeister CenterColumbus, Ohio  43219