Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer

NCT00216073 | Terminated Phase 2 DMC

• 1 other identifier: HOG BRE03-61
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 11

Brief Summary

In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• - · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer.

  18 months

Secondary Outcomes (4)

• To measure time to progression

  18 months

• To determine rate of clinical benefit response (CR + PR + SD > 6 months)

  18 months

• To determine toxicity rate of CAPOX-T in this patient population

  18 months

• To explore potential correlations between changes in HER2 circulating extracellular domain in the primary tumor with response

  18 months

Study Arms (1)

1

ACTIVE COMPARATOR

Capecitabine + Oxaliplatin + trastuzumab. Patients must be HER2 positive.

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Trastuzumab

Interventions

Capecitabine DRUG

Capecitabine 825 mg/m2 po bid, days 1-14

1

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 IV, day 1

1

Trastuzumab DRUG

Trastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only.

1

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.·
• HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry.·
• At least one measurable lesion as defined by the RECIST.
• Prior hormonal therapy for metastatic disease is allowed.
• Maximum of one prior chemotherapy regimen or trastuzumab-containing regimen for unresectable, locally recurrent or metastatic disease
• Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.

You may not qualify if:

• No prior therapy with capecitabine or oxaliplatin in any setting
• No prior therapy with other platinum compounds·
• No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.·
• No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.·
• No prior fluoropyrimidine therapy for metastatic disease is allowed.
• Prior adjuvant fluoropyrimidine therapy is allowed if completed \> 12 months from study entry.·
• No symptomatic brain metastasis. ·
• No evidence of serious concomitant systemic disorders incompatible with the study ·
• No peripheral neuropathy ·
• No major surgery within 28 days prior to beginning protocol therapy.·
• Negative pregnancy test·
• No current breastfeeding·
• No malabsorption syndrome·
• No evidence of serious concomitant systemic disorders incompatible with the study·
• Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Sanofi: collaborator
• Hoffmann-La Roche: collaborator
• Walther Cancer Institute: collaborator

Study Sites (11)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Community Regional Cancer Center

Indianapolis, Indiana, 46256, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Center for Hematology/Oncology of S. Michigan

Jackson, Michigan, 49201, United States

Location

Related Links

• Hoosier Oncology Group Home Page

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Oxaliplatin; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kathy Miller, M.D.

  Hoosier Oncology Group, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

US (11)