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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00277069
Other study ID # 2899C
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 12, 2006
Last updated January 6, 2010
Start date May 2000
Est. completion date March 2006

Study information

Verified date October 2008
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.


Description:

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.

3. Determine the time to relapse after the administration of this regimen.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date March 2006
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patient must have a histological diagnosis of breast cancer with metastasis.

- The metastatic disease should be confirmed by biopsy if clinically indicated.

- The patient must have measurable or evaluable disease.

- Age > 18 years and < 75 years.

- The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.

- The patient may have received herceptin previously.

- The patients must have previously received at least one cycle of chemotherapy.

- The patient must have received anthracycline and taxane containing chemotherapy in the past. This may be either in the adjuvant setting or for metastatic disease. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy.

- Performance status < 2.

- At least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4 associated toxicities at the time of registration. Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present.

- Patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease.

- The patient should not have uncontrolled CNS disease.

- Laboratory parameters: ANC > l500/ l, Platelets >100 000/ l, creatinine < 2.0, bilirubin < 2.0

- Informed consent.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Carboplatin
Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
Device:
Capecitabine
Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
Drug:
Vinorelbine
Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study. disease progression or unacceptable toxicities Yes
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