Expired Study
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Columbus, Ohio 43210


Purpose:

This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab.


Study summary:

Rationale: Previous studies have demonstrated the anti-tumor efficacy of gemcitabine and trastuzumab against metastatic breast cancer when given alone and in combination. Yet, research indicates that the two drugs given together work more effectively than either alone. Laboratory studies testing the combination of trastuzumab and cisplatin have shown synergistic anti-tumor activity with the two drugs. In addition, clinical studies suggest a high level of anti-tumor activity with the combination of gemcitabine and cisplatin. Researchers are testing the triple drug combination of gemcitabine, trastuzumab, and cisplatin in the current study to evaluate the potential for enhanced responsiveness in patients with Her-2/neu overexpressing breast cancer as well as comparing it to the double drug combination of gemcitabine and trastuzumab. Purpose: This study will measure patient responses and compare the efficacy of a double drug combination (gemcitabine and trastuzumab) with a triple drug combination (gemcitabine, trastuzumab, and cisplatin) in patients with metastatic breast cancer. Side effects will be carefully assessed in patients. Treatment: Patients in this study will receive one of two treatment combinations. A computer will randomly assign patients to a treatment group. Group one will be given gemcitabine and trastuzumab. Gemcitabine will be given to patients on days 1 and 8, and trastuzumab on days 1, 8, and 15. Group two will receive gemcitabine, trastuzumab, and cisplatin. Gemcitabine and cisplatin will both be administered on days 1 and 8, and trastuzumab on days 1, 8, and 15. Each treatment cycle (for both groups) will last a total of 21 days. All study drugs will be administered through intravenous infusions. Several tests and exams will be given throughout the study to closely monitor patients. Thorough patient exams will be given at the beginning of each treatment cycle. Imaging tests will be done every two cycles for the first eight cycles and then every three cycles until study completion. Study treatment will be discontinued due to disease growth or unacceptable side effects.


Criteria:

Eligibility Criteria: - Must have invasive metastatic breast cancer - Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University pathology)or positive FISH - Histological confirmation of invasive breast cancer either from the original diagnosis and/or diagnosis of metastatic disease. - Tumor must be detectable clinically or radiographically (a positive bone scan is allowed as the only site of disease). Unidimensional measurements must be obtained whenever possible). Bone marrow only disease is not eligible for enrollment on this study. - No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO. Patients must have normal LV function and LVEF(left ventricular ejection fraction)> 50% as demonstrated by either echo or muga within the proceeding 4 weeks. - Must have adequate renal and hepatic function documented by a serum creatinine < 1.5 x the institutional upper limit of normal (ULN), serum bilirubin <1.5 x ULN and liver enzymes (AST, ALT, or alkaline phosphatase) < 2 x ULN (< 5 x ULN if hepatic metastasis) within 21 days prior to registration. - Patients must have an ANC (absolute neutrophil count) > 1.5, platelets > 100,000, Hemoglobin >9.0 within 21 days of registration. - If patients are on bisphosphonates at the time of registration, with a stable creatinine over the preceding 2 months, then they may continue bisphosphonates during the study. - No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination for metastatic disease. Additional Trastuzumab therapy may have been given in the adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic disease. - Must be >3 weeks since administration of last chemotherapy prior to initiation of treatment on this trial. Prior trastuzumab may have been administered within one week of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period. - Patients may have received prior cisplatin or carboplatin for metastatic disease. - No CNS(central nervous system)metastasis disease. - No active infection at time of registration. - Pregnant or nursing women may not participate in trial. - Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. - ECOG (Eastern Cooperative Oncology Group)performance status < 2 at the time of registration. - Patients may participate in a non-treatment related protocol while participating in this study. - No other active malignancy is allowed. Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years is allowed.


Study is Available At:


Original ID:

OSU-0342


NCT ID:

NCT00201760


Secondary ID:


Study Acronym:


Brief Title:

Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer


Official Title:

A Randomized Phase II Study of Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kari Kendra, MD
Principal Investigator
Ohio State University

Study Dates

Start Date:February 25, 2005
Completion Date:October 31, 2009
Completion Type:Actual
Primary Completion Date:October 31, 2009
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 30, 2017
First Received Date:September 12, 2005
First Results Date:June 15, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations
Time Frame:Up to 24 months
Safety Issues:False
Description:Adverse Events will be graded in accordance with the CTCAE Version 3.0 Toxicity grading criteria
Outcome Type:Secondary Outcome
Measure:Measure Response Rate of Each Drug Combination
Time Frame:Up to 24 months
Safety Issues:False
Description:Response rate of the of the triple drug combination therapy and the double drug combination therapy regimens.
Outcome Type:Primary Outcome
Measure:Disease Progression
Time Frame:6 months
Safety Issues:False
Description:Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment

Study Interventions

Intervention Type:Drug
Name:Gemcitabine
Description:1000 mg/m2 IV over 30 minutes on Days 1 and 8.
Arm Name:Arm 1 Gemcitabine/Cisplatin/Trastuzumab
Other Name:Gemzar
Intervention Type:Drug
Name:Trastuzumab
Description:2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.
Arm Name:Arm 1 Gemcitabine/Cisplatin/Trastuzumab
Other Name:Herceptin
Intervention Type:Drug
Name:Cisplatin
Description:30 mg/m2 IV on Day 1 and Day 8.
Arm Name:Arm 1 Gemcitabine/Cisplatin/Trastuzumab
Other Name:Platinol®-AQ

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm 2 Gemcitabine / Trastuzumab
Description:Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).
Study Arm Type:Experimental
Arm Name:Arm 1 Gemcitabine/Cisplatin/Trastuzumab
Description:Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kari Kendra
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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