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This study has been withdrawn prior to enrollment.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:
CTI BioPharma
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01227408
First received: January 8, 2009
Last updated: May 19, 2014
Last verified: May 2014

January 8, 2009
May 19, 2014
February 2009
February 2009   (final data collection date for primary outcome measure)
Response [ Time Frame: At surgical resection on about week 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01227408 on ClinicalTrials.gov Archive Site
Toxicity [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
February 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01227408
1B-08-7
Yes
Agustin Garcia, MD, USC/Norris Comprehensive Cancer Center
University of Southern California
CTI BioPharma
Not Provided
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP