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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
doxorubicin, paclitaxel poliglumex, capecitabine, cyclophosphamide, methotrexate
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Patients with confirmed breast cancer for neoadjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metronomic Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Toxicity

Full Information

First Posted
January 8, 2009
Last Updated
April 29, 2017
Sponsor
University of Southern California
Collaborators
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01227408
Brief Title
Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
Official Title
Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdrew due to funding issues
Study Start Date
February 2009 (Anticipated)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
CTI BioPharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Patients with confirmed breast cancer for neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metronomic Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
doxorubicin, paclitaxel poliglumex, capecitabine, cyclophosphamide, methotrexate
Intervention Description
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
Primary Outcome Measure Information:
Title
Response
Time Frame
At surgical resection on about week 30
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
Every 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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