ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00404404
• Other study ID #: CDR0000515534
• Secondary ID: PREMIERE-AVF3678
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 27, 2006
• Last updated: December 17, 2013
• Start date: October 2006

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.

Description:

OBJECTIVES:

Primary

• Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) and bevacizumab, in terms of progression-free survival and response rate, in women with recurrent or metastatic breast cancer.

Secondary

• Determine the toxicity profile of this regimen in these patients.

• Determine the feasibility of this regimen in these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer

• Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent

• Measurable or nonmeasurable disease

• No CNS metastases by CT scan or MRI

• No HER2-neu-positive tumors

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female

• Menopausal status not specified

• Performance status 0-1

• Absolute neutrophil count = 1,500/mm³

• Platelet count > 100,000/mm³

• Creatinine < 2.0 mg/dL

• Bilirubin normal

• AST = 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement)

• Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR = 1 g protein on 24-hour urine collection

• No peripheral neuropathy > grade 1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin

• No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications

• No prior hypertensive crisis or hypertensive encephalopathy

• No New York Heart Association class II-IV congestive heart failure

• No myocardial infarction or unstable angina within the past 6 months

• No stroke or transient ischemic attack within the past 6 months

• No significant vascular disease (e.g., aortic aneurysm or aortic dissection)

• No symptomatic peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy

• No significant traumatic injury within the past 28 days

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No serious, nonhealing wound, ulcer, or bone fracture

• No known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

• No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) or bevacizumab

• No prior chemotherapy for metastatic disease

• Prior hormonal therapy for metastatic disease allowed

• At least 4 weeks since any prior therapy for cancer

• More than 12 months since prior adjuvant chemotherapy, including use of a taxane

• More than 28 days since prior major surgery or open biopsy

• More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)

• No concurrent major surgery

• No other concurrent therapy for breast cancer

• Concurrent bisphosphonates allowed if there is bone involvement

• No concurrent prophylactic granulocyte colony-stimulating factors

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• paclitaxel albumin-stabilized nanoparticle formulation

Locations

Country	Name	City	State
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Premiere Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival as measured by RECIST criteria at 1 and 2 years			No
Secondary	Response rate measured every 3 courses during treatment			No
Secondary	Overall survival			No
Secondary	Time to progression			No
Secondary	Disease-free survival			No
Secondary	Toxicity			Yes