Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer

NCT00216021 | Completed Phase 2 DMC

• 1 other identifier: HOG BRE03-60
• Study Type: interventional
• Target: 25
• 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. This trial will investigate the activity of this novel capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition, an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples.

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  36 months

Secondary Outcomes (4)

• To measure time to progression ·

  36 months

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

  36 months

• To determine toxicity rate of CAPOX in this patient population.·

  36 months

• To explore potential correlations between thymidine synthase (TS), thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD) expression in the primary tumor with response.

  36 months

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Capecitabine + Oxaliplatin

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

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

Single Group Assignment

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 IV, day 1

Single Group Assignment

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.·
• Patients with HER2 positive (3+ overexpression by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.·
• At least one measurable lesion as defined by the RECIST.
• 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.·
• Maximum of one prior chemotherapy regimen for unresectable, locally recurrent or metastatic disease·
• 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 female patients currently 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)

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, 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

Center for Cancer Care, Inc., P.C.

New Albany, Indiana, 47150, 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

Related Links

• Hoosier Oncology Group Home Page

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Oxaliplatin

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

Study Officials

• Kathy Miller, M.D.

  Hoosier Oncology Group, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, IU School of Medicine

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (11)