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

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ClinicalTrials.gov Identifier: NCT00216073
Recruitment Status : Terminated (Lack of patient accrual)
First Posted : September 22, 2005
Last Update Posted : May 2, 2011
Sponsor:
Collaborators:
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Capecitabine Drug: Oxaliplatin Drug: Trastuzumab Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

  • CAPOX-T (21 day cycle):Capecitabine 825 mg/m2 orally twice daily Days 1-14Oxaliplatin 100 mg/m2 intravenously Day 1
  • Trastuzumab : 6 mg/kg intravenously Day 1.8mg/kg loading dose should be given in cycle 1 for patients without previous trastuzumab therapy only.

Patients may continue combination therapy until progression or toxicity intervenes. Patients who discontinue either or both cytotoxic agents due to toxicity may, at the investigators discretion, continue therapy with the remaining agents on study until progressive disease

ECOG performance status 0 or 1

Hematopoietic:·

  • ANC > 1,200/mm3·
  • Platelets > 100,000/mm3

Hepatic:·

  • Total bilirubin < 1.5 x ULN·
  • AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)

Renal:·

  • Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated with Cockroft-Gault equation

Cardiovascular:·

  • No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.·
  • LVEF > LLN by MUGA or ECHO

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Capecitabine, Oxaliplatin and Trastuzumab (CAPOX-T) in Patients With HER-2 Positive Metastatic Breast Cancer: Hoosier Oncology Group BRE03-61
Study Start Date : March 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 1
Capecitabine + Oxaliplatin + trastuzumab. Patients must be HER2 positive.
Drug: Capecitabine
Capecitabine 825 mg/m2 po bid, days 1-14

Drug: Oxaliplatin
Oxaliplatin 100 mg/m2 IV, day 1

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




Primary Outcome Measures :
  1. - · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. To measure time to progression [ Time Frame: 18 months ]
  2. To determine rate of clinical benefit response (CR + PR + SD > 6 months) [ Time Frame: 18 months ]
  3. To determine toxicity rate of CAPOX-T in this patient population [ Time Frame: 18 months ]
  4. To explore potential correlations between changes in HER2 circulating extracellular domain in the primary tumor with response [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216073


Locations
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United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
AP&S Clinic
Terre Haute, Indiana, United States, 47804
United States, Michigan
Center for Hematology/Oncology of S. Michigan
Jackson, Michigan, United States, 49201
Sponsors and Collaborators
Hoosier Cancer Research Network
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Investigators
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Study Chair: Kathy Miller, M.D. Hoosier Oncology Group, LLC

Additional Information:
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Responsible Party: Kathy Miller, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00216073     History of Changes
Other Study ID Numbers: HOG BRE03-61
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by Hoosier Cancer Research Network:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Oxaliplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological