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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

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Metastases, Neoplasm

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Trial Information

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

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

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.

Inclusion 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

- Patient has an expected survival of at least 12 weeks

- Patient or his/her representative has signed an informed consent statement

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Michael J Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Metastases, Neoplasm
  • Metastatic Breast Cancer
  • Taxol
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis



Abraxis Bioscience, Inc. Durham, North Carolina  27703