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

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00277069
First received: January 12, 2006
Last updated: January 6, 2010
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Breast
Cancer
Drug: Carboplatin
Device: Capecitabine
Drug: Vinorelbine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

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. [ Time Frame: disease progression or unacceptable toxicities ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: May 2000
Study Completion Date: March 2006
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Xeloda
    Drug: Vinorelbine
    Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days
    Other Name: Navelbine
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277069

Locations
United States, New Mexico
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
  More Information

No publications provided

Responsible Party: Ian Rabinowitz, MD, University of New Mexico CRTC
ClinicalTrials.gov Identifier: NCT00277069     History of Changes
Other Study ID Numbers: 2899C
Study First Received: January 12, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Breast metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Capecitabine
Carboplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014