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

NCT ID: NCT00277069

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2006-03-31

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.

Conditions

Breast; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Carboplatin

Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days

Intervention Type: DRUG

Capecitabine

Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days

Intervention Type: DEVICE

Vinorelbine

Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days

Intervention Type: DRUG

Other Intervention Names

Xeloda; Navelbine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

University of New Mexico CRTC

Principal Investigators

Ian Rabinowitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

2899C

Identifier Type: -

Identifier Source: org_study_id