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

NCT00277069 | Completed Phase 1 DMC

• 1 other identifier: 2899C
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast; Cancer

Keywords

Breast metastatic

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Carboplatin DRUG

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

Capecitabine DEVICE

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

Also known as: Xeloda

Vinorelbine DRUG

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

Also known as: Navelbine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Carboplatin; Vinorelbine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Ian Rabinowitz, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: May 1, 2000
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2006
• Last Updated: January 7, 2010

Record last verified: 2008-10

Locations

US (1)