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
16 Years
N/A
Both
Breast Neoplasms, Metastases, Neoplasm
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: 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
Authority:
United States: Food and Drug Administration
Study ID:
CA012-0
NCT ID:
NCT00046527
Start Date:
June 2001
Completion Date:
Related Keywords:
- Breast Neoplasms
- Metastases, Neoplasm
- Metastatic breast cancer
- Taxol
- Taxane
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Abraxis Bioscience, Inc | Durham, North Carolina 27703 |
