Trials / Completed
CompletedNCT00028873
R101933 Combined With Chemotherapy in Treating Patients With Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
An EORTC-IDBBC/ECSG Phase II Study Evaluating The Role Of The Multi-Drug Resistance (MDR) Reversor, R101933, In Patients With Taxane Refractory Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor cells to be killed. PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy.
Detailed description
OBJECTIVES: * Determine the activity of R101933 in combination with paclitaxel or docetaxel in terms of response to treatment and level of clinical benefit in patients with taxane-refractory metastatic breast cancer. * Determine the safety of this regimen in these patients. * Determine the acute side effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive R101933 IV over 1 hour immediately followed by paclitaxel IV over 3 hours or docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients who have no disease progression after 7 courses may continue with treatment at the investigator's discretion. Patients are followed every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | docetaxel | |
| DRUG | laniquidar | |
| DRUG | paclitaxel |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2002-06-01
- First posted
- 2003-01-27
- Last updated
- 2012-07-18
Locations
2 sites across 2 countries: Belgium, France
Source: ClinicalTrials.gov record NCT00028873. Inclusion in this directory is not an endorsement.