Breast Neoplasms Clinical Trial
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
NCT number | NCT00046514 |
Other study ID # | CA013 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | September 30, 2002 |
Last updated | December 14, 2016 |
Start date | June 2001 |
Verified date | December 2016 |
Source | Celgene Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Abraxis BioScience, Inc. | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Celgene Corporation |
United States,
Blum JL, Savin MA, Edelman G, Pippen JE, Robert NJ, Geister BV, Kirby RL, Clawson A, O'Shaughnessy JA. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer. 2007 Dec;7(11):850-6. doi: 10.3816/CBC.2007.n.049. — View Citation
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 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
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 |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A |