Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00046527
Other study ID # CA012-0
Secondary ID
Status Completed
Phase Phase 3
First received September 30, 2002
Last updated July 12, 2006
Start date June 2001

Study information

Verified date October 2004
Source Celgene Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
ABI-007


Locations

Country Name City State
United States Abraxis Bioscience, Inc Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Active, not recruiting NCT03664778 - Abbreviated Breast MRI After Cancer Treatment
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Active, not recruiting NCT04568902 - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Phase 1
Completed NCT02860585 - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation N/A
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT03698942 - Delphinus SoftVueâ„¢ ROC Reader Study
Completed NCT00092950 - Exercise in Women at Risk for Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Not yet recruiting NCT02151071 - The Breast Surgery EnLight and LightPath Imaging System Study Phase 1/Phase 2
Recruiting NCT02934360 - TR(ACE) Assay Clinical Specimen Study N/A
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02931552 - Nuevo Amanecer II: Translating a Stress Management Program for Latinas N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Recruiting NCT02547545 - Breast Cancer Chemotherapy Risk Prediction Mathematical Model N/A
Completed NCT02303366 - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 Phase 1
Completed NCT02518477 - Preventive Intervention Against Lymphedema After Breast Cancer Surgery N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A