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Home > "I" Clinical Trials Conditions > ICI 182780 in Treating Women With Metastatic Breast Cancer  ICI 182780 in Treating Women With Metastatic Breast Cancer
ICI 182780 in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,stage 3C breast cancer,recurrent breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
Details: OBJECTIVES: - Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant. - Determine the time to disease progression and overall survival of women treated with this drug. - Determine the toxicity of this drug in these women. OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 41-94 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the breast - Progressive local-regional or metastatic disease - Unconfirmed new or progressive multiple pulmonary nodules or unequivocal radiographic evidence of multiple bone metastases allowed - At least 1 measurable lesion - At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan - Nonmeasurable disease includes the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusions - Lymphangitis cutis/pulmonis - Inflammatory breast disease - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - Disease progression after prior third-generation aromatase inhibitor (e.g., anastrozole, exemestane, letrozole, or vorozole) - Failed no more than 1 prior additive hormonal therapy (e.g., aromatase inhibitor with or without tamoxifen) - Disease recurrence identified no more than 12 months since the last prior adjuvant tamoxifen treatment - Oophorectomy, ovarian radiotherapy, and luteinizing hormone-releasing hormone (LH-RH) analogs not considered hormonal therapy regimens - No brain or leptomeningeal metastases - No hepatic metastases involving more than one-third of the liver - No symptomatic pulmonary lymphangitic disease - Evidence of hormone sensitivity as defined by: - Relapse after at least 12 months of adjuvant hormonal treatment - Tumor remission or stabilization before progression for at least 6 months after prior hormonal therapy for advanced disease - Postmenopausal as defined by one of the following: - At least 12 months since last menstrual period - 4-11 months since last menstrual period and follicle-stimulating hormone (FSH) in the postmenopausal range - Prior castration and castrate FSH levels within the postmenopausal range - Hysterectomy without oophorectomy (FSH in postmenopausal range if age 60 and under) - Hormone receptor status: - Estrogen-receptor and/or progesterone-receptor positive - At least 10 fmol/mg cytosol protein OR - Positive by immunohistochemistry PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - See Disease Characteristics - Postmenopausal Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - No history of bleeding diathesis Hepatic: - See Disease Characteristics - Bilirubin no greater than 0.8 mg/dL above upper limit of normal (ULN) - INR no greater than 1.6 - No hepatitis B or C - No severe hepatic impairment Renal: - Calcium no greater than 10% above ULN - Creatinine no greater than 1 mg/dL above ULN - No severe renal impairment Cardiovascular: - No unstable or uncompensated cardiac condition Pulmonary: - No unstable or uncompensated respiratory condition Other: - HIV negative - No AIDS - No other severe condition or systemic disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior trastuzumab (Herceptin) allowed Chemotherapy: - Prior adjuvant chemotherapy allowed - No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy: - See Disease Characteristics - More than 4 weeks since prior estrogen replacement therapy - More than 3 months since prior LH-RH analogs - No other prior additive hormonal therapy except third-generation aromatase inhibitors or tamoxifen Radiotherapy: - See Disease Characteristics - Concurrent radiotherapy for control of bone pain or other reasons due to established bone lesions allowed if radiotherapy field is no more than 30% of bone marrow Surgery: - See Disease Characteristics Other: - More than 4 weeks since prior investigational drug for breast cancer - No concurrent long-term warfarin - Concurrent bisphosphonates allowed if dose stable - Concurrent long-term antiplatelet therapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesIngle, Study Chair, Mayo Clinic Cancer Center
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
Carle Foundation Hospital - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-6846
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting James Ingle 507-284-2511
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Additional Information:
Study ID Numbers: CDR0000068473; NCCTG-N0032
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012025
Other Stage 4 Breast Cancer Studies:
1. Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
2. ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
3. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
4. ICI 182780 in Treating Women With Metastatic Breast Cancer
5. Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
ICI 182780 in Treating Women With Metastatic Breast Cancer
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