Clinical trial NCT00297596: Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
Official title: A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Metastatic
HER2/neu+
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-02-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer

Detailed description: Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab until disease progression.

Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles.

For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab

Eligibility criteria: Inclusion Criteria:

* Females ≥ 18 years of age
* Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type
* Measurable disease by RECIST and an ECOG ≤ 2
* Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)
* Baseline LVEF value within the institutional normal range
* Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.
* Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.
* Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.
* Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.
* All prior chemotherapy, trastuzumab and radiation therapy should be completed \> 2 weeks before enrollment.
* Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within \< 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.
* Patients must have recovered from toxicities due to prior therapy.
* Lab values in accordance with the protocol
* Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).

Exclusion Criteria:

* Bone only disease are ineligible
* Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.
* Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.
* Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.
* Uncontrolled nervous system metastases
* Dementia or significantly altered mental status that would interfere with proper consenting.
* Receiving other investigational therapy.

Primary outcomes:
measure: Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: 18 months
Secondary outcomes:
measure: Time to Progression
timeFrame: 18 months
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Alexandria
country: United States
facility: Hematology Oncology Life Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yardley DA, Daniel D, Stipanov M, Drosick DR, Mainwaring M, Peyton J, Shastry M, Hainsworth JD. A phase II trial of oxaliplatin and trastuzumab in the treatment of HER2-positive metastatic breast cancer. Cancer Invest. 2010 Oct;28(8):865-71. doi: 10.3109/07357901003631031.