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Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer


OBJECTIVES:

- Compare the probability of clinical response in estrogen receptor (ER)-positive vs
ER-negative patients with recurrent, persistent, or metastatic endometrial cancer
treated with fulvestrant.

- Compare the relationship between response rate and intensity of receptor expression in
patients treated with this drug.

- Determine the frequency and intensity of toxicity of this drug in these patients.

OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28
days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that
is not curable with surgery or radiotherapy

- Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

- ER positive or negative allowed

- Measurable disease

- At least 1 target lesion not within a previously irradiated field OR irradiated
target lesion with clear disease progression

- At least 20 mm by conventional techniques, including palpation, x-ray, CT scan,
MRI, OR at least 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥100,000/mm^3

- No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor
deficiency, or requirement for anticoagulants)

Hepatic:

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

- SGOT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

Renal:

- Creatinine ≤ 2 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to castor oil

- No other concurrent malignancy except nonmelanoma skin cancer

- No other prior malignancy within past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer

- No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that
has subsequently recurred

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response by RECIST criteria evaluated every 8 weeks

Safety Issue:

No

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000068339

NCT ID:

NCT00006903

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphia, Pennsylvania  19102
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
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
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
SUNY Downstate Medical CenterBrooklyn, New York  11203
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202