ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

NCT00394082 | Completed Phase 2 Results

• 1 other identifier: CA043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab. The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer, Abraxane, Bevacizumab

Outcome Measures

Primary Outcomes (2)

• Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

  Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.

  up to 25 months

• Kaplan-Meier Estimates for Progression-free Survival

  Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a \>= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

  up to 39 months

Secondary Outcomes (4)

• Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

  up to 39 months

• Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

  up to 39 months

• Kaplan-Meier Estimate for Duration of Response

  up to 39 months

• Kaplan-Meier Estimates for Participant Survival

  up to 39 months

Study Arms (1)

ABI-007 plus Bevacizumab

EXPERIMENTAL

ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.

Drug: ABI-007; Drug: Bevacizumab

Interventions

ABI-007 DRUG

125 mg/m\^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle.

Also known as: Abraxane®, Nab-paclitaxel

ABI-007 plus Bevacizumab

Bevacizumab DRUG

Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.

Also known as: NSC 704865, RhuMAb VEGF, Recombinant Humanized Monoclonal Bevacizumab Antibody

ABI-007 plus Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed adenocarcinoma of the breast.
• Stage IV disease.
• Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral computed tomography (CT) scan).
• Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by fluorescence in situ hybridization (FISH) or 3 + overexpression by ICH) and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin-based therapy would be inappropriate or not indicated).
• For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction \>50% or above institution's lower limit of normal and a normal electrocardiogram (ECG) (as assessed by the investigator).
• At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.
• International Normalized Ratio (INR) \< 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Female \> 18 years of age.
• Patients have the following blood counts at Baseline: absolute neutrophil count (ANC) greater or equal to 1.5 x 10\^9 cells/L; platelets greater or equal 100 x 10\^9 cells/L; hemoglobin (Hgb) greater or equal to 9g/dL.
• Patients have the following blood chemistry levels at Baseline: aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT) less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.
• if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.
• if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
• Informed consent has been obtained.

You may not qualify if:

• No prior chemotherapy for metastatic or locally recurrent disease is allowed.
• Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.
• if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.
• if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.
• Concurrent immunotherapy or hormonal therapy.
• Parenchymal brain metastases, including leptomeningeal involvement.
• Uncontrolled hypertension (defined as blood pressure of \> 150/100 mmHg)
• NYHA Grade 2 or greater congestive heart failure
• History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
• Urine protein:creatinine ratio less than or equal to 1.0 at screening.
• No history of cerebrovascular accident within six months of study entry.
• Active symptomatic peripheral vascular disease (e.g. aortic aneurysm, claudication) within six months of study entry.
• Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.
• No serious non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Celgene: lead

Study Sites (20)

Unknown Facility

Melbourne, Florida, 32901, United States

Location

Unknown Facility

Ocoee, Florida, 34761, United States

Location

Unknown Facility

Niles, Illinois, 60714, United States

Location

Unknown Facility

Terre Haute, Indiana, 47802, United States

Location

Unknown Facility

Columbia, Maryland, 21044, United States

Location

Unknown Facility

Westminister, Maryland, 21157, United States

Location

Unknown Facility

Saint Joseph, Missouri, 64507, United States

Location

Unknown Facility

Rochester, New York, 14623, United States

Location

Unknown Facility

Bedford, Texas, 76022, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

El Paso, Texas, 79915, United States

Location

Unknown Facility

Odessa, Texas, 79761, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Tyler, Texas, 75702, United States

Location

Unknown Facility

Fairfax, Virginia, 22031, United States

Location

Unknown Facility

Norfolk, Virginia, 23502, United States

Location

Unknown Facility

Salem, Virginia, 24153, United States

Location

Unknown Facility

Burien, Washington, 98166, United States

Location

Unknown Facility

Edmonds, Washington, 98026, United States

Location

Unknown Facility

Vancouver, Washington, 98684, United States

Location

Related Publications (1)

• Danso M, et al. Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer. Presented at 2008 ASCO Annual Meeting, May 30-June 3, 2008, Chicago, IL. Abstract No. 1075.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Limitations and Caveats

Interpretation of results is limited since the cell receptor subtype status of patients is not known.

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: October 31, 2006
• Study Start: June 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2011
• Last Updated: November 25, 2019
• Results First Posted: May 22, 2013

Record last verified: 2019-11

Locations

US (20)