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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
Onyx Pharmaceuticals |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00499525 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel together with sorafenib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well paclitaxel works when given together with or without sorafenib in treating patients with locally recurrent or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: paclitaxel Drug: sorafenib tosylate Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo When Administered in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer |
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: paclitaxel
given IV
Drug: sorafenib tosylate
given orallly
|
|
Active Comparator: Arm II
Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: paclitaxel
given IV
Other: placebo
given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to site of metastatic disease (visceral [i.e., soft internal organs of the body, including lungs, heart, and the organs of the digestive, excretory, and reproductive systems] vs nonvisceral [i.e., osseous or soft tissue] sites). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and every 8 weeks for 24 weeks, and then every 12 weeks for the duration of study participation.
After completion of study therapy, patients are followed every 4 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Locally recurrent or metastatic disease
No HER-2 overexpression (defined as positive for gene amplification by FISH or 3+ overexpression by IHC)
No active brain metastases
Patients with neurological symptoms and known brain metastases treated with definitive therapy must undergo contrast CT scan or brain MRI to exclude active brain metastasis
PATIENT CHARACTERISTICS:
INR ≤ 1.5 and aPTT within normal limits
Anticoagulation therapy (e.g., warfarin or heparin) allowed
No clinically significant cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior radiotherapy
More than 30 days or 5 half-lives, whichever is longer, since prior investigational drug
Contacts and Locations
Show 43 Study Locations| Study Chair: | William J. Gradishar, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | William J. Gradishar, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00499525 History of Changes |
| Other Study ID Numbers: | NU 07B1, NU 07B1, STU00000776 |
| Study First Received: | July 10, 2007 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
|
male breast cancer recurrent breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer stage IIIA breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Sorafenib Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |