Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Breast; Cancer

• Registration Number: NCT00277069
• Lead Sponsor: University of New Mexico

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2005-03
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Study Completion: 2006-03
• Status Verified: 2008-10
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States