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S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: anastrozole (Drug); goserelin acetate (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Zeina Nahleh, MD, Affiliation: Barrett Cancer Center
Abdul-Rahman Jazieh, MD, MPH, Affiliation: Barrett Cancer Center
Robert B. Livingston, MD, Affiliation: University of Washington
Gabriel N. Hortobagyi, MD, FACP, Affiliation: M.D. Anderson Cancer Center

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin and anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving goserelin together with anastrozole may be an effective treatment for male breast cancer. PURPOSE: This phase II trial is studying how well giving goserelin together with anastrozole works in treating men with recurrent or metastatic breast cancer.

Clinical Details

Official title: A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Progression-free survival (PFS)

Overall survival

Overall objective tumor response rate (confirmed and unconfirmed, complete and partial)

Correlation of prostate specific antigen, testosterone, estradiol, estrone, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS

Toxicity

Detailed description: OBJECTIVES:

- Determine the progression-free survival (PFS) of men with estrogen receptor- or

progesterone receptor-positive recurrent or metastatic breast cancer treated with goserelin and anastrozole.

- Determine the overall survival of patients treated with this regimen.

- Determine the overall objective tumor response rate (confirmed and unconfirmed,

complete and partial) in patients with measurable disease treated with this regimen.

- Correlate prostate specific antigen (PSA), testosterone, estradiol, estrone, estrone

sulfate, follicle-stimulating hormone, luteinizing hormone, and dehydroepiandrosterone levels with PFS and response in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive goserelin subcutaneously on day 1 and oral anastrozole on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at approximately 4-6 weeks and then every 3-6 months for up to 3 years. PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 48 months.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast cancer

- Recurrent or metastatic (stage IV) disease

- Patients with a local regional recurrence, including axillary and/or chest

wall involvement, are eligible

- Measurable or non-measurable disease

- Brain metastases allowed provided they have been treated with surgery or radiotherapy

AND have remained stable for ≥ 3 months

- Hormone receptor status:

- Estrogen receptor- OR progesterone receptor- positive disease by standard

immunohistochemical techniques PATIENT CHARACTERISTICS: Age

- 18 and over

Sex

- Male

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No evidence of severe or uncontrolled hepatic disease

Renal

- No evidence of severe or uncontrolled renal disease

Cardiovascular

- No evidence of severe or uncontrolled cardiac disease

Pulmonary

- No evidence of severe or uncontrolled respiratory disease

Other

- Fertile patients must use effective barrier-method contraception during and for 12

weeks after the completion of study treatment

- No known HIV positivity

- Able to receive oral medication

- Patients with a gastrointestinal tube are eligible

- No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH

agonist analogues, or any components of the study drugs

- No active infection requiring systemic therapy

- No other malignancy within the past 5 years except adequately treated basal cell or

squamous cell skin cancer

- No evidence of other severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY: Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors

Chemotherapy

- At least 14 days since prior chemotherapy for this cancer and recovered

- No more than 1 prior chemotherapy regimen for metastatic disease

- No concurrent chemotherapy

Endocrine therapy

- At least 14 days since prior hormonal therapy for this cancer and recovered

- Prior tamoxifen allowed

- No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or

fulvestrant

- No other concurrent hormonal therapy (e. g., estrogen-based therapies)

Radiotherapy

- See Disease Characteristics

- At least 14 days since prior radiotherapy for this cancer and recovered

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

Locations and Contacts

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089-9181, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado 80045, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

Montrose Memorial Hospital Cancer Center, Montrose, Colorado 81401, United States

Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, United States

Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida 33316, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States

Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas 67401, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan 48202, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65802, United States

St. John's Regional Health Center, Springfield, Missouri 65804, United States

Billings Clinic Cancer Center, Billings, Montana 59107-5100, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

Deaconess Billings Clinic - Downtown, Billings, Montana 59107-7000, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States

Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States

St. Vincent Healthcare, Billings, Montana 59101, United States

Bozeman Deaconess Hospital, Bozeman, Montana 59715, United States

St. James Community Hospital, Butte, Montana 59701, United States

Great Falls, Montana 59405, United States

Great Falls Clinic, Great Falls, Montana 59405, United States

St. Peter's Hospital, Helena, Montana 59601, United States

Glacier Oncology, PLLC, Kalispell, Montana 59901, United States

Kalispell Medical Oncology, Kalispell, Montana 59901, United States

Kalispell Regional Medical Center, Kalispell, Montana 59901, United States

Community Medical Center, Missoula, Montana 59801, United States

Guardian Oncology and Center for Wellness, Missoula, Montana 59804, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States

Rutherford Hospital, Rutherfordton, North Carolina 28139, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Community Oncology Group at Cleveland Clinic Cancer Center, Independence, Ohio 44131, United States

Cleveland Clinic - Wooster, Wooster, Ohio 44691, United States

AnMed Health Cancer Center, Anderson, South Carolina 29621, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming 82801, United States

Additional Information

Starting date: September 2005
Last updated: January 2, 2013

Page last updated: August 23, 2015

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