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Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer Patients Who Have Failed an Anthracycline (CAT) (CAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01446016
Recruitment Status : Recruiting
First Posted : October 4, 2011
Last Update Posted : September 14, 2016
The Methodist Hospital System
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital System

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Drug: Taxane Drug: Taxotere Drug: Abraxane Drug: Ixabepilone Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2011
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Taxane
Drug: 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)
Drug: Taxotere
Chloroquine 250mg po daily together with Taxotere 75 mg/m2 administered intravenously over one hour every three weeks
Other Name: Taxne-like
Drug: Abraxane
Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.
Other Name: Taxane-like
Drug: Ixabepilone
Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Other Name: Taxane-like

Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: One Year ]
    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).

Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: One Year ]
    To assess the safety and tolerability of the combination of Chloroquine and Taxane or Taxane-Like chemo.

  2. Tumor Control Rate [ Time Frame: One Year ]
    To assess the response rate and tumor control rate (TCR) of patients receiving Chloroquine + Taxane or Taxane-like.

  3. Time to Progression [ Time Frame: One Year ]
    To assess the Time to Progression (TTP) of patients receiving Chloroquine + Taxane or Taxane-like chemo.

  4. Duration of Response [ Time Frame: Three Years ]
    To assess the duration of response (DOR) of patients receiving Chloroquine + Taxane or Taxane-like chemo agents.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Females with pathologically determined advanced or metastatic breast cancer.
  2. Have progressed after treatment with regimen that included an anthracycline.
  3. Have had at least 4 cycles of an anthracycline containing regimen or 2 cycles if progressing on treatment.
  4. Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors.
  5. ≥18 years of age.
  6. ECOG PS of 0, 1, or 2.
  7. Laboratory values within the following ranges:

    • Hemoglobin ≥9.0gm/dL (≥1.5μmol/L); transfusions permitted.
    • Absolute neutrophil count ≥1500/mm3 (1.5 x 109/L)
    • Platelet count ≥100,000/mm3 (100 x 109/L)
    • Creatinine (Cr) <2 X the upper limit of normal (ULN), Cr clearance (CrCl) ≥30 by Cockcroft and Gault
    • Alanine aminotransferase and aspartate aminotransferase <2 X the ULN; if liver metastases are present then must be <5 X the ULN, Bilirubin <2 X the ULN, Potassium within normal limits, Magnesium within normal limits
  8. Negative serum pregnancy test at the time of first dose for women of childbearing potential (WOCBP). For WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
  9. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  10. Patient must be willing to undergo breast biopsies as required by the study protocol.

Exclusion Criteria:

  1. Radiation therapy within 2 weeks; or chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating study treatment.
  2. Evidence of New York Heart Association class III or greater cardiac disease.
  3. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months.
  4. History of congenital QT prolongation.
  5. QT >500.
  6. Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  7. Symptomatic central nervous system metastases. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week.
  8. Pregnant or nursing women.
  9. Hypersensitivity or intolerance to Chloroquine, Paclitaxel, Docetaxel, Abraxane, Ixabepilone or other Taxane like drugs.
  10. Severe renal insufficiency (CrCl <30mL/min [Cockcroft and Gault]).
  11. History of gastrointestinal bleeding, ulceration, or perforation.
  12. Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole, itraconazole,clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
  13. Concurrent use of potent CYP3A4 inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbitol, and St. John's wort.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446016

Contact: Cancer Center Research 713-441-0629

United States, Texas
Houston Methodist Hospital Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Cancer Center Research    713-441-0629   
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         
Houston Methodist Hospital Willowbrook Recruiting
Houston, Texas, United States, 77070
Contact: Houston Methodist Cancer Center    713-441-0629   
Principal Investigator: Anna Belcheva, MD         
Houston Methodist Hospital Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
Contact: Houston Methodist Cancer Center    713-441-0629   
Principal Investigator: Jorge Darcourt, MD         
Sponsors and Collaborators
Jenny C. Chang, MD
The Methodist Hospital System
Principal Investigator: Jenny C Chang, MD The Methodist Hospital System

Responsible Party: Jenny C. Chang, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System Identifier: NCT01446016     History of Changes
Other Study ID Numbers: 0811-0147
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined

Keywords provided by Jenny C. Chang, MD, The Methodist Hospital System:
Breast Cancer
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Mammary Carcinoma, Human
Mammary Neoplasm, Human
Mammary Neoplasms, Human
Neoplasms, Breast
Tumors, Breast
Metastatic Breast Cancer
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Chloroquine diphosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs