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

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT00277069

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Carboplatin Device: Capecitabine Drug: Vinorelbine	Phase 1/Phase 2

Detailed Description

Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
Determine the time to relapse after the administration of this regimen.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator: Ian Rabinowitz, MD, University of New Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00277069

Other Study ID Numbers:

2899C

First Posted:

Jan 13, 2006

Last Update Posted:

Jan 7, 2010

Last Verified:

Oct 1, 2008

Keywords provided by , ,

Breast metastatic

Additional relevant MeSH terms:

Carboplatin

Capecitabine

Vinorelbine

Study Results

No Results Posted as of Jan 7, 2010