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

This study has been withdrawn prior to enrollment.
(Sponsor withdrew due to funding issues)
Sponsor:
Collaborator:
Cell Therapeutics
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01227408
First received: January 8, 2009
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: doxorubicin, paclitaxel poliglumex, capecitabine, cyclophosphamide, methotrexate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response [ Time Frame: At surgical resection on about week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227408

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Cell Therapeutics
  More Information

No publications provided

Responsible Party: Agustin Garcia, MD, USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01227408     History of Changes
Other Study ID Numbers: 1B-08-7
Study First Received: January 8, 2009
Last Updated: October 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by USC/Norris Comprehensive Cancer Center:
Patients with confirmed breast cancer for neoadjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Fluorouracil
Capecitabine
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013