ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer - Full Text View

Sponsor:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00046514

Purpose

The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.

Condition	Intervention	Phase
Breast Neoplasms Metastases, Neoplasm	Drug: ABI-007	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Clinical Trial of ABI-007 (A Cremophor-Free, Protein Stabilized, Nanoparticle Paclitaxel)Administered Weekly in Taxol Resistant Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Abraxis BioScience Inc.:

Estimated Enrollment:	100
Study Start Date:	June 2001

Detailed Description:

The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.

In this study, the test medication (ABI-007) is a nanoparticle colloidal composition of protein-stabilized paclitaxel that is reconstituted in saline. The infusion time for ABI-007 is minimal compared to Taxol (under an hour), and there is no premedication required. The maximally tolerated dose of this formulation of paclitaxel is 300 mg/m2, as compared to 175 mg/m2 for Taxol. As tumor response has been shown to be dose-dependent for paclitaxel, a higher dose allows for a potentially better response.

This open-label, Phase II study will determine the safety, tolerability and anti-tumor effect of ABI-007 monotherapy administered weekly in patients with metastatic breast cancer that have been previously treated with Taxol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients must be:

If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
Eighteen years of age or older
Karnofsky Perfomance Status of 70% or 0-2 SWOG Performance Status
No other malignancy, except non-melanoma skin cancer, CIN, or in-situ cervical cancer
Measurable disease
Suitable candidate for treatment with paclitaxel
Previously treated with Taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
If, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dL
If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dL; creatinine levels less than or equal to 2 mg/dL; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
Patient has an expected survival of at least 12 weeks
Patient or his/her representative has signed an informed consent statement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046514

Locations

United States, North Carolina
Abraxis BioScience, Inc.
Raleigh, North Carolina, United States, 27609

Sponsors and Collaborators

Abraxis BioScience Inc.

Investigators

Study Director:

Michael J Hawkins, M.D.

Abraxis BioScience Inc.

More Information

No publications provided

Study ID Numbers:	CA013-0
Study First Received:	September 30, 2002
Last Updated:	July 18, 2007
ClinicalTrials.gov Identifier:	NCT00046514 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

Metastatic Breast Cancer
Taxol

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes

Neoplasms by Site
Pathologic Processes
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Neoplasm Metastasis
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on March 18, 2010