Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer - Full Text View

Sponsored by:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00046527

Purpose

Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required.

This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer.

This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in 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:	460
Study Start Date:	June 2001

Detailed Description:

Taxol (Bristol-Meyers Squibb) is active against carcinomas of the ovary, breast, lung, esophagus and head and neck. A number of dose schedules of Taxol have been tested in breast cancer. Initial trials used 250 mg/m2 as a continuous infusion over 24 hours. Subsequently, shorter infusions of Taxol over three hours were tested at a dose of 175 mg/m2, with response rates of 30%-40%. Phase II studies using higher doses of Taxol at 200-250 mg/m2 had a response rate of 56% in metastatic breast cancer patients. However, at these doses, significant toxicities occurred, including neuropathy. There was a median granulocyte count nadir at 100-200 cells/mm3 for the majority of courses administered. There were also significant side effects associated with hypersensitivity to the Taxol vehicle, Cremophor-EL. These hypersensitivity reactions require a premedication schedule that includes a corticosteroid, an H2 antagonist and an antihistamine.

Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor. This formulation is a protein-stabilized, nanoparticle suspension of paclitaxel and human serum albumin in normal saline. The potential advantages of this formulation are:

Higher tolerated doses, with greater efficacy
Longer drug persistence in tumor as a result of the nanoparticle formulation
Reduced infusion time
Reduced risk of hypersensitivity with no required premedication schedule
More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data

This study will evaluate ABI-007, as compared to Taxol, in patients with metastatic breast cancer.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients will be eligible for this trial if:

Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception
Sixteen years of age or older
Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease
If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane
No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer
Suitable candidate for paclitaxel therapy
Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL
Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis
Expected survival of at least 12 weeks
Patient or his/her representative has signed an informed consent form

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046527

Locations

United States, North Carolina
Abraxis Bioscience, Inc
Durham, North Carolina, United States, 27703

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:	CA012-0
Study First Received:	September 30, 2002
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00046527 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

Metastatic breast cancer
Taxol
Taxane

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Neoplasm Metastasis

Breast Neoplasms
Taxane
Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009