Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
This study has been terminated.
(Lack of patient accrual)
Sponsor:
Hoosier Oncology Group
Collaborators:
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00216073
First received: September 9, 2005
Last updated: April 29, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Capecitabine Drug: Oxaliplatin Drug: Trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Hoosier Oncology Group:
Primary Outcome Measures:
- - · 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To measure time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To determine rate of clinical benefit response (CR + PR + SD > 6 months) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To determine toxicity rate of CAPOX-T in this patient population [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To explore potential correlations between changes in HER2 circulating extracellular domain in the primary tumor with response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | March 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216073
Locations
| 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 | |
| Quality Cancer Center (MCGOP) | |
| Indianapolis, Indiana, United States, 46202 | |
| Indiana University Cancer Center | |
| 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 Oncology Group
Sanofi
Hoffmann-La Roche
Walther Cancer Institute
Investigators
| Study Chair: | Kathy Miller, M.D. | Hoosier Oncology Group, LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kathy Miller, M.D., Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00216073 History of Changes |
| Other Study ID Numbers: | HOG BRE03-61 |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hoosier Oncology Group:
|
Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Oxaliplatin Trastuzumab Capecitabine Fluorouracil |
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 May 23, 2013