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Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer



- Evaluate the tumor response rate in patients with previously treated metastatic breast
cancer treated with vinflunine and capecitabine.


- Describe the adverse event profile of this regimen in these patients.

- Determine the progression-free survival of patients treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the duration of response in patients treated with this regimen.

- Determine the time to treatment failure in patients treated with this regimen.

- Describe the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on
days 1-14. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, every other course, and at the completion of study

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed breast cancer meeting the following

- Metastatic disease

- Previously treated with 1-2 chemotherapy regimens for metastatic disease

- Measurable disease, defined as ≥ 1 measurable lesion ≥ 2.0 cm by conventional
techniques OR ≥ 1.0 cm by spiral CT scan

- No nonmeasurable disease, including any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen (unless
there is a contraindication) if tumor is HER2 positive (3+ by immunohistochemistry or
amplified by fluorescent in situ hybridization [FISH])

- No CNS metastasis unless controlled by prior surgery and/or radiotherapy

- "Controlled" is defined as ≥ 2 months of no symptoms or evidence of progression

- Currently enrolled on clinical trial QOL N0392

- Hormone receptor status not specified

- Hormone-positive tumor must meet at least 1 of the following criteria:

- Tumor refractory to hormonal therapy

- Heavy visceral tumor burden that requires chemotherapy for better and
faster control of metastatic disease

- Relapsed disease during adjuvant hormonal therapy and failed first-line

- Not treated with hormonal therapy because of side effects or adverse events


- Male or female

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 8.0 g/dL

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

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

- Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

- AP normal AND AST and ALT ≤ 5 times ULN

- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST and ALT normal

- Creatinine clearance ≥ 30 mL/min

- Serum sodium normal

- Not pregnant or nursing

- No nursing during and for 30 days after completion of study therapy

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study therapy

- No history of allergy or hypersensitivity to drug product excipients or to agents
chemically similar to vinflunine and/or capecitabine

- No prior unanticipated severe reaction to fluoropyrimidine therapy

- No known hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency

- No active, unresolved infection

- No New York Heart Association class III-IV cardiovascular disease, unstable angina,
myocardial infarction within the past 6 months, or poorly controlled hypertension

- No preexisting neuropathy ≥ grade 2

- No concurrent serious medical condition that would preclude study treatment

- No other stage III or IV invasive cancer within the past 3 years

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

- Ability to complete questionnaires alone or with assistance


- See Disease Characteristics

- Prior unlimited hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic

- No major surgery, chemotherapy, or immunologic therapy within the past 4 weeks

- No radiotherapy within the past 4 weeks, except if to a nontarget lesion only

- Prior radiotherapy to a target lesion is allowed if there has been clear
progression of the lesion since radiotherapy was completed

- If patient received single-dose radiotherapy or palliation to a nontarget lesion
only, the patient may immediately proceed to study registration without waiting
4 weeks

- No prior fluoropyrimidines, including capecitabine, or vinca alkaloids (e.g.,
vinorelbine, vinblastine, vincristine, or vindesine) for metastatic breast cancer

- No prior radiotherapy to > 30% of bone marrow-containing areas

- No cimetidine, allopurinol, sorivudine, or brivudine within the past 2 weeks

- No ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir within the past 2

- No concurrent treatment in another clinical trial in which investigational procedures
are performed or investigational therapies are administered

- No concurrent trastuzumab (Herceptin®)

- No concurrent hormonal therapy

- No concurrent interleukin-11

- No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy

- No concurrent administration of any of the following:

- Cimetidine

- Allopurinol

- Sorivudine

- Brivudine

- Ketoconazole

- Itraconazole

- Ritonavir

- Amprenavir

- Indinavir

- Wwarfarin allowed if patient is on a stable dose and has an INR < 3.0

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response

Safety Issue:


Principal Investigator

Alvaro Moreno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

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