|
|
|
|
|
|
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00265733 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Drug: capecitabine Drug: paclitaxel poliglumex |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Paclitaxel Capecitabine Paclitaxel Poliglumex |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | February 2006 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologic or cytologic confirmation of breast cancer with clinical evidence of metastatic disease
Measurable disease, defined as at least one measurable lesion
No non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 2.0 cm) and truly non-measurable lesions, which include the following:
Hormone receptor status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
No current or recent use (≤ 2 weeks prior to registration) of aspirin, anticoagulants or thrombolytic agents
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Investigator: | Edith A. Perez, MD | Mayo Clinic |
Investigator: | Timothy Hobday, MD | Mayo Clinic |
Study Chair: | Donald W. Northfelt, MD, FACP | Mayo Clinic Scottsdale |
Investigator: | Daniel W. Visscher, MD | Mayo Clinic |
Investigator: | Mark Rodacker, MD | Medcenter One Hospital Cancer Care Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000456449, NCCTG-N0437 |
First Received: | December 14, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00265733 |
Health Authority: | United States: Federal Government |
|
|
|
|
|