Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer

April 29, 2017 updated by: University of Southern California

Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer

The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and capecitabine. It is expected this combination will at least maintain the efficacy of a traditional chemotherapy regimen but will be associated with less toxicity, particularly nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a chemotherapy regimen whose components (or administration schedule) are associated with minimal or no alopecia and are also considered to have low emetogenic potential.

In an attempt to improve the efficacy of the regimen the investigators plan to study an alternate schedule of cyclophosphamide and methotrexate administration (metronomic chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of conventional cytotoxic chemotherapy administered concurrently.

In this trial the investigators aim to determine the clinical and pathologic response rate of 12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy with cyclophosphamide and methotrexate will be administered during the 24 weeks of chemotherapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • SWOG performance status of 0-2
  • Projected life expectancy of at least 3 months
  • Female age 18 years and over
  • Provision of informed consent prior to any study-related procedures.
  • Hormone receptor positive or negative tumor
  • Her 2 neu negative tumor
  • Negative pregnancy test for women of childbearing potential
  • Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • ANC > 1500, Platelet count > 100,000, Hemoglobin > 9.0
  • Serum creatinine < 1.5 mg/dl
  • Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal. Serum Bilirubin < 1.5 mg
  • Peripheral neuropathy grade 0-1
  • No other concomitant therapy directed at the cancer is allowed.

Exclusion Criteria:

  • Serum bilirubin > 1.5 the upper limit of reference range (ULRR)
  • Serum creatinine >1.5
  • Prior therapy for this tumor.
  • Clinical Congestive Heart Failure
  • Women who are currently pregnant or breast feeding.
  • Receipt of any investigational agents within 30 days prior to commencing study treatment
  • Prior radiation must not have included ≥ 30% of major bone marrow containing areas (pelvis, lumbar spine)
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in-situ of the breast (LCIS), or any other cancer from which the patient has been disease-free for 5 years. Patients with prior invasive breast cancer or ductal carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years and did not receive prior treatment with doxorubicin and/or a taxane.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metronomic Chemotherapy
Doxorubicin will be administered as an intravenous bolus, careful intravenous injection. PPX will be administerd as an intravenous 10 mins. infusion. Capecitabine and methotrexate will be taken orally twice a day. Cyclophosphamide will be taken orally once a day.
Drug: doxorubicin, paclitaxel poliglumex, capecitabine, cyclophosphamide, methotrexate
doxorubicin 20mg/m2 weekly x 12 wks, cyclophosphamide 50 mg PO qd x 12 wks, methotrexate 2.5 mg PO bid d1,2 wkly x 12. One week later paclitaxel poliglumex 135mg/m2 IV every 3 wks plus capecitabine 825 mg/m2 PO bid x 14days x 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: At surgical resection on about week 30
At surgical resection on about week 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: Every 4 weeks
Every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

CTI BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 29, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1B-08-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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