Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer

NCT ID: NCT00503906

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-03-31

Brief Summary

The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.

Detailed Description

This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abraxane, Avastin and Gemcitabine

Each treatment cycle is 28 days. Participants will be treated until disease progression:

• Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
• Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
• Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.

Group Type: EXPERIMENTAL

Avastin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Abraxane

Intervention Type: DRUG

Interventions

Avastin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Abraxane

Intervention Type: DRUG

Other Intervention Names

Bevacizumab; Gemzar; Albumin-Bound Paclitaxel Formulation

Eligibility Criteria

Inclusion Criteria

1. Patients must either be:

• treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or
• HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).

2. No previous chemotherapy regimen for metastatic breast cancer.

3. 18 years of age or older.

4. Measurable disease as defined by RECIST criteria or evaluable disease.

5. Eastern Cooperative Oncology Group (ECOG) 0-1.

6. Life expectancy greater than 3 months.

7. For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study

8. Provide written informed consent before any study-related procedure not part of normal medical care is conducted

9. Willing and able to comply with the protocol requirement

10. Laboratory parameters as follows:

• Neutrophils: 1.5 x109/L or greater
• Platelets: 100 x109/L or greater
• Hemoglobin: ≥ 9.0 g/dL
• Serum Creatinine: ≤ 1.5mg/dL
• Bilirubin: ≤ ULN, except when caused by metastatic disease
• Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease
• Urine protein creatinine (UPC) ratio < 1.0 at screening.

Exclusion Criteria

1. Previous treatment with gemcitabine.

2. History of Gastrointestinal Bleeding in the previous 3 months.

3. Chemotherapy within 4 weeks prior to enrollment.

4. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.

5. Any major surgery within 4 weeks prior to enrollment.

6. Presence of central nervous system or brain metastases.

7. Urine protein: creatinine ratio ≥ 1.0 at screening.

8. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).

9. A prior history of hypertensive crisis or hypertensive encephalopathy.

10. Peripheral neuropathy > grade I.

11. Clinical AIDS or known positive HIV serology

12. No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.

13. Unstable angina.

14. New York Heart Association (NYHA) Grade II or greater congestive heart failure

15. History of myocardial infarction within 6 months.

16. History of stroke within 6 months.

17. Clinically significant peripheral vascular disease.

18. Evidence of bleeding diathesis or coagulopathy

19. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.

20. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.

21. Pregnant (positive pregnancy test) or lactating.

22. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment

23. Serious, non-healing wound, ulcer, or bone fracture

24. Inability to comply with study and/or follow-up procedures

25. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.

26. Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Glück, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

Lobo C, Lopes G, Baez O, Castrellon A, Ferrell A, Higgins C, Hurley E, Hurley J, Reis I, Richman S, Seo P, Silva O, Slingerland J, Tukia K, Welsh C, Gluck S. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):427-35. doi: 10.1007/s10549-010-1002-0. Epub 2010 Jun 29.

Reference Type: RESULT

PMID: 20585851 (View on PubMed)

Other Identifiers

SCCC-2006081

Identifier Type: OTHER

Identifier Source: secondary_id

20060913

Identifier Type: -

Identifier Source: org_study_id