Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia

Completed · Phase 2

Conditions studied: Breast Cancer, Neutropenia

In brief

The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor \[G-CSF\]) in breast cancer patients at high (\>20%) risk for chemotherapy-induced severe neutropenia.

Key facts

Study ID

NCT00497809

Run by

AviGenics

People needed

189

Starts

2007-08-01

Expected to finish

2009-07-01

Last updated by the study team

2011-05-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
• Women, aged 18 years and older
• Histologically confirmed breast cancer, undergoing one of a variety of chemotherapy regimens, or with other risk factors that could lead to a >20% risk of developing severe neutropenia. Patients receiving chemotherapy regimens with high-risk for severe neutropenia are eligible; eligibility of patients receiving intermediate-risk chemotherapy regimens must be discussed with the Medical Monitor for the presence of additional patient-specific risk factors.
• Must be receiving first-line adjuvant or neoadjuvant therapy for localized breast cancer or first-line chemotherapy for metastatic breast cancer. It is recommended that patients with human epidermal growth factor receptor 2 (HER2/neu)-positive breast cancer should be receiving Herceptin® (trastuzumab), if approved and available for this indication.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of grade 0 to 2
• Adequate renal (serum creatinine and blood urea nitrogen [BUN] <3 times the upper limit of normal [ULN]) and hepatic (serum bilirubin, aspartate aminotransferase [AST], and alanine aminotransferase [ALT] <3 times ULN) function.
• Able to adhere to the study visit schedule and other protocol requirements.
• Women who are not pregnant and do not plan to become pregnant during the study. Women of childbearing potential must have a negative serum pregnancy test result within seven days before the first dose of study drug and must be using adequate non hormonal barrier contraception before entering the study and throughout the study. Non childbearing potential is defined as post-menopausal for at least one year, surgically sterile, or having had a hysterectomy before study start.

You may not qualify if…

• Pregnant or lactating women.
• History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, or hematologic disease, which in the opinion of the investigator will interfere with study participation.
• Metastatic brain or meningeal tumors.
• Ascites or pleural effusions.
• Any active infection requiring systemic antimicrobial therapy.
• Known to be positive for human immunodeficiency virus (HIV, anti-HIV+), hepatitis B antigen (HBAg[+]), or hepatitis C antibody (HCVAb[+]).
• Known or suspected hypersensitivity to the study drug or its components, such as avian products, including influenza vaccine, or to E. coli-derived proteins.
• Currently receiving radiation therapy for treatment of a malignant condition, or have completed radiation therapy within 14 days before study entry. Radiation therapy for oncologic emergency is allowed.
• Participated in another therapeutic clinical study (i.e., not an epidemiological study or genomic screening study) during the past 30 days, or are likely to simultaneously participate in another therapeutic clinical study.
• History of, or known current problems with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patient's participation in the study, or with evaluation of the study results.
• Any condition that could jeopardize the patient's safety and compliance, as judged by the investigator.

Where it is running

• Pacific Cancer Medical Center — Anaheim, California, United States
• California Cancer Center — Greenbrae, California, United States
• Ghassan Al-Jazayrly, MD, Inc. — Los Angeles, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
• Brian LeBerthon, MD, A Medical Corporation — West Covina, California, United States
• Infosphere Clinical Research — West Hills, California, United States
• Physicians Research Alliance LLC. — DeBary, Florida, United States
• Southern Illinois Hematology/Oncology — Centralia, Illinois, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
• University of Oklahoma Health Sciences Ctr — Oklaoma City, Oklahoma, United States
• Cancer Care Institute of Carolina — Aiken, South Carolina, United States
• Cancer Specialists of South Texas — Corpus Christi, Texas, United States
• Cancer Outreach Associates PC — Abingdon, Virginia, United States
• Jawaharlal Nehru Cancer Hospital and Research Centre — Idgah Hills, Bhopal, India
• Apollo Specialty Hospital, Padma Complex — 320 Mount Road, Chennai, India
• Amrita Institute of Medical Sciences — Amrita Lane Elamakkara, Cochin, India
• Apollo Hospitals Educational and Research Foundation — Jubilee Hills, Hyderabad, India
• Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road — Bangalore, Karnataka, India
• Mohan Dai Oswal Cancer Treatment & Research Foundation — G.T. Road, Sherpur Bye Pass, Ludhiana, India
• Dayanand Medical College and Hospital — Tagore Nagar, Civil Lines, Ludhiana, India
• Meenakshi Mission Hospital and Research Centre — Lake Area, Melur Road, Madurai,, India
• Kasturba Medical College Hospital — Attavar, Mangalore, India
• Tata Memorial Hospital, — Dr. E Borges Road, Parel, Mumbai, India
• Dharamshila Hospital and research Centre — Vasundhara Enclave, National Capital Territory of Delhi, India

Full record on ClinicalTrials.gov

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