Efficacy and Safety of Chloroquine in Combination With Taxane or Taxane-like Chemotherapy in the Treatment of Advanced or Metastatic Breast Cancer Patients Who Have Failed an Anthracycline (CAT)
The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed anthracycline based therapy.
The investigators want to see the response of breast cancer cell when treated with Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of The Efficacy And Safety of Chloroquine (C) in CombinAtion With Taxane or Taxane-like (T) Chemo Agents in The Treatment of Patients With Advanced or Metastatic Breast Cancer Who Have Failed Anthracycline Chemo Base Therapy.|
- Overall Response Rate (ORR) [ Time Frame: One Year ] [ Designated as safety issue: No ]To determine the anti-tumor activity of the combination of Chloroquine + Taxane or Taxane-like chemo agents (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) (C/T) measured by overall Response Rate (ORR).
- Safety and Tolerability [ Time Frame: One Year ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of the combination of Chloroquine and Taxane or Taxane-Like chemo.
- Tumor Control Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]To assess the response rate and tumor control rate (TCR) of patients receiving Chloroquine + Taxane or Taxane-like.
- Time to Progression [ Time Frame: One Year ] [ Designated as safety issue: No ]To assess the Time to Progression (TTP) of patients receiving Chloroquine + Taxane or Taxane-like chemo.
- Duration of Response [ Time Frame: Three Years ] [ Designated as safety issue: No ]To assess the duration of response (DOR) of patients receiving Chloroquine + Taxane or Taxane-like chemo agents.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Taxane
Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.
Other Name: Paclitaxel
Active Comparator: Taxane-Like
Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone)
Chloroquine 250mg po daily together with Taxotere 75 mg/m2 administered intravenously over one hour every three weeks
Other Name: Taxne-likeDrug: Abraxane
Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.
Other Name: Taxane-likeDrug: Ixabepilone
Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Other Name: Taxane-like
The purpose of this study is to determine the anti-tumor activity of the combination of Chloroquine combined with a Taxane or Taxane-like chemo agents(Paclitaxel, Docetaxel, Abraxane, Ixabepilone).
The laboratories have developed robust preclinical models utilizing both in vitro systems such as the mammosphere (MS) culture and in vivo systems such as human breast cancer xenografts allowing the investigators to identify agents which selectively target TICs, as single agents or in combination. These models are critical since tumor initiating cells (TICs) comprise only a small percentage of the tumor bulk, so that clinical tumor regression may not be observed with inhibitors that selectively target TIC self-renewal alone. Nonetheless, these agents in combination with conventional therapy may effectively kill both actively cycling or fully differentiated cells and the TIC subpopulation, leading to long term remission and eradication of cancer cells.
|Contact: Cancer Center Researchfirstname.lastname@example.org|
|United States, Texas|
|The Methodist Hospital Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cancer Center Research 713-441-0629 email@example.com|
|Principal Investigator: Jenny Chang, MD|
|Sub-Investigator: Angel A. Rodriguez, MD|
|Sub-Investigator: Daniel Lehane, MD|
|Sub-Investigator: Monisha Singh, MD|
|Sub-Investigator: Tejal Patel, MD|
|Sub-Investigator: Jorge Darcourt, MD|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital System|