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

NCT00497809 | Completed Phase 2 DMC

• 1 other identifier: AVI-014-P02
• Study Type: interventional
• Target: 189
• Locations: 2 countries
• Sites: 31

Brief Summary

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.

Conditions

Breast Cancer; Neutropenia

Keywords

Breast Cancer; Neutropenia; Chemotherapy; High risk

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.

  First cycle of GCSF

Secondary Outcomes (1)

• • Incidence of grade 4 neutropenia • Duration of neutropenia (defined as the number of days with ANC <0.5 x 109/L and <0.1 x 109/L)

  Cycle 1

Study Arms (4)

1

EXPERIMENTAL

AVI-014 2.5mcg/kg

Drug: AVI-014 versus Filgrastim

2

EXPERIMENTAL

AVI-014 5.0 mcg/kg

Drug: AVI-014 versus Filgrastim

3

EXPERIMENTAL

AVI014 10.0 mcg/kg

Drug: AVI-014 versus Filgrastim

4

ACTIVE COMPARATOR

Filgrastim 5.0 mcg/kg

Drug: AVI-014 versus Filgrastim

Interventions

AVI-014 versus Filgrastim DRUG

3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AviGenics: lead

Study Sites (31)

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

California Cancer Center

Greenbrae, California, 94904-2007, United States

Location

Ghassan Al-Jazayrly, MD, Inc.

Los Angeles, California, 90027, United States

Location

Desert Hematology Oncology Medical Group

Rancho Mirage, California, 92270, United States

Location

Brian LeBerthon, MD, A Medical Corporation

West Covina, California, 91790, United States

Location

Infosphere Clinical Research

West Hills, California, 91307, United States

Location

Physicians Research Alliance LLC.

DeBary, Florida, 32713, United States

Location

Southern Illinois Hematology/Oncology

Centralia, Illinois, 62801, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44781, United States

Location

Signal Point Clinical Research Center, LLC

Middletown, Ohio, 45042, United States

Location

University of Oklahoma Health Sciences Ctr

Oklaoma City, Oklahoma, 73104, United States

Location

Cancer Care Institute of Carolina

Aiken, South Carolina, 29801, United States

Location

Cancer Specialists of South Texas

Corpus Christi, Texas, 78412, United States

Location

Cancer Outreach Associates PC

Abingdon, Virginia, 24211, United States

Location

Jawaharlal Nehru Cancer Hospital and Research Centre

Idgah Hills, Bhopal, 462001, India

Location

Apollo Specialty Hospital, Padma Complex

320 Mount Road, Chennai, 600 035, India

Location

Amrita Institute of Medical Sciences

Amrita Lane Elamakkara, Cochin, 682026, India

Location

Apollo Hospitals Educational and Research Foundation

Jubilee Hills, Hyderabad, 500033, India

Location

Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road

Bangalore, Karnataka, 560 029, India

Location

Mohan Dai Oswal Cancer Treatment & Research Foundation

G.T. Road, Sherpur Bye Pass, Ludhiana, 141009, India

Location

Dayanand Medical College and Hospital

Tagore Nagar, Civil Lines, Ludhiana, 141001, India

Location

Meenakshi Mission Hospital and Research Centre

Lake Area, Melur Road, Madurai,, 625107, India

Location

Kasturba Medical College Hospital

Attavar, Mangalore, 576104, India

Location

Tata Memorial Hospital,

Dr. E Borges Road, Parel, Mumbai, 400 012, India

Location

Dharamshila Hospital and research Centre

Vasundhara Enclave, National Capital Territory of Delhi, 10096, India

Location

Indraprastha Apollo Hospital

Delhi Mathura Road, Sarita Vihar, New Delhi, 110076, India

Location

IRCH, AIIMS, Ansari Nagar,

New Delhi, New Delhi, 110029, India

Location

Dharamshila Cancer Center, Dharamshila Marg

Vasundhara Enclave, New Delhi, 110096, India

Location

Regional Cancer Centre, IGIMS

Sheikhpura, Patna, 800014, India

Location

Ruby Hall Clinic

40 Sasoon Road, Pune, 411001, India

Location

King George Hospital

Vizag, Vishakhapattanam, 110076, India

Location

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Howard Ozer, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Robert J. Grieve, M.B,Ch.B., FRCR

  University Hospitals of Coventry and Warwickshire

  PRINCIPAL INVESTIGATOR

• Walter Kraft, MD, MS, FACP

  AviGenics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 9, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

IN (17); US (14)