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

Breast Cancer Clinical Trial

Official title:

A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503906
• Other study ID #: 20060913
• Secondary ID: SCCC-2006081
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2007
• Last updated: May 10, 2017
• Start date: June 2007
• Est. completion date: March 2011

Study information

• Verified date: May 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Avastin

• Gemcitabine

• Abraxane

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Glück S. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Progression-Free Survival	Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.	Up to 24 months
Secondary	Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants	Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.	After two cycles, about 60 days
Secondary	Rate of Toxicity in Study Participants	Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.	Over the course of study treatment.
Secondary	Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment	Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.	Baseline, over the course of Treatment, about 1 year
Secondary	Relationship Between SPARC Expression and Response to Protocol Therapy.	Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.	Baseline, over the course of treatment, about 1 year