ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00046514
First received: September 30, 2002
Last updated: July 18, 2007
Last verified: July 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


Further study details as provided by Celgene Corporation:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Celgene Corporation
Investigators
Study Director: Michael J Hawkins, M.D. Celgene Corporation
  More Information

No publications provided

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

Keywords provided by Celgene Corporation:
Metastatic Breast Cancer
Taxol

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014