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

University of New Mexico (UNM)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast; Cancer

Treatments: Device: Capecitabine; Drug: Vinorelbine; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00277069

2899C

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)