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Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer


- Assess the tumor response rate and adverse event profile in patients with metastatic,
HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and

- Examine the distributions of disease-free progression times and survival times in these

OUTLINE: This is a multicenter study.

Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and
oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Inclusion Criteria


- Histologic or cytologic confirmation of breast cancer with clinical evidence of
metastatic disease

- No bone metastases as the only evidence of metastasis

- Measurable disease, defined as at least one measurable lesion

- No non-measurable disease, defined as all other lesions, including small lesions
(longest diameter < 2.0 cm) and truly non-measurable lesions, which include the

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- No known brain metastasis

- HER2 negative disease by immunohistochemistry and/or fluorescent in situ

- Diagnostic tissue and operative and pathology reports from breast cancer diagnosis
and/or diagnosis of metastatic breast cancer must be available

- Hormone receptor status

- Not specified


- Males or females are eligible

- Menopausal status: not specified

- Life expectancy ≥ 3 months

- ECOG performance status 0 or 1

- Any serum estradiol level allowed

- Hemoglobin > 8.0 g/dL

- Absolute neutrophil count ≥ 1500/mL

- Platelet count ≥ 100,000/mL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- AST and ALT ≤ 2.5 times UNL

- Calcium normal

- Creatinine clearance ≥ 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Women of childbearing potential or their sexual partners must be willing to employ
adequate contraception (as determined by the treating physician) for the duration of
the study and for 30 days after treatment has ended

- No stage III or IV invasive, non-breast malignancies in ≤ 5 years prior to

- No history of allergy or hypersensitivity to capecitabine, paclitaxel, or

- No prior unanticipated severe reaction to fluoropyrimidine therapy

- No known DPD deficiency

- No known, existing uncontrolled coagulopathy

- No uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that
would limit compliance with study requirements

- No lack of physical integrity of the upper gastrointestinal tract, clinically
significant malabsorption syndrome, or inability to take oral medication

- No significant medical condition that would make treatment or follow-up on this
protocol difficult or problematic, in the opinion of the treating oncologist

- No preexisting neuropathy > grade 0


- No other concurrent cytotoxic agents, investigational drugs, immunotherapy, radiation
therapy or hormonal therapy

- Capecitabine must not be administered together with antiviral drugs

- No concurrent allopurinol, metronidazole, or sorivudine (or its chemically-related
analogues, such as brivudine)

- Cimetidine must be discontinued at least 2 weeks prior to start of study treatment
and must be avoided while taking capecitabine

- Patients receiving bisphosphonates are eligible for this study

- No prior chemotherapy for metastatic disease

- Prior anthracycline and/or taxane in the neoadjuvant or adjuvant setting allowed if
completed ≥ 6 months prior to registration

- Unlimited prior hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic

- No HIV-positive individuals receiving combination anti-retroviral therapy

- No major surgery, chemotherapy, or immunologic therapy ≤ 4 weeks prior to

- No radiotherapy ≤ 4 weeks prior to registration, except to a non-target lesion only

- Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed

- If patient receives single dose radiation for palliation, they may immediately
proceed to registration without waiting 4 weeks

- Neoadjuvant and/or adjuvant therapy must be completed > 6 months prior to

- No current or recent use (≤ 2 weeks prior to registration) of aspirin, anticoagulants
or thrombolytic agents

- Agents to maintain patency of a vascular access device is permitted

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria

Safety Issue:


Principal Investigator

Edith A. Perez, MD

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms