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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277069
• Other study ID #: 2899C
• 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

• Breast
• Cancer

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