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Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00834678
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : April 22, 2015
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Genentech, Inc.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: bendamustine
Drug: erlotinib
Drug: Maintenance erlotinib
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
53
(38 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
11
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  18.2%
White
9
  81.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
ECOG (Eastern Cooperative Oncology Group) performance status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
0 (Fully active) 4
1 (Restricted) 6
2 (Ambulatory and capable selfcare) 1
Site of metastasis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Lymph nodes 9
Lung/pleura 6
Bone 4
Liver 3
Chest wall/skin 3
Brain 1
[1]
Measure Description: A patient can be represented among multiple sites
Prior chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Adjuvant only 4
Metastasis/local recurrence only 1
Both 6
Total number of prior treatment regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
1 prior regimen 4
2 prior regimens 7
1.Primary Outcome
Title Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)
Hide Description 28 day cycle included intravenous bendamustine on days 1 and 2.
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.

Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: mg/m^2
120
2.Primary Outcome
Title Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)
Hide Description 28 day cycle included intravenous erlotinib on days 15-21.
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.

Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: mg
150
3.Primary Outcome
Title Dose-limiting Toxicity (Phase I)
Hide Description [Not Specified]
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: patients
Dose level I, n=5 0
Dose level II, n=6 1
4.Primary Outcome
Title Progression-free Survival at 6 Months and 12 Months (Phase II)
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 11
Mean (95% Confidence Interval)
Unit of Measure: months
3.7
(1.7 to 5.5)
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: patients
Dose Level 1 0
Dose Level 2 1
6.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description [Not Specified]
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected and analyzed
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:
Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Duration of Response (DR)
Hide Description [Not Specified]
Time Frame Up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months to progression
3.7
(1.7 to 5.5)
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame from time of study enrollment until death, for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
10.8
(3.6 to 13.1)
9.Secondary Outcome
Title Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS
Hide Description [Not Specified]
Time Frame up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Correlative studies to assess EGFR expression and gene amplification, were planned, but not collected because of early trial termination.
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description:

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years
Adverse Event Reporting Description This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
 
Arm/Group Title Bendamustine and Erlotinib
Hide Arm/Group Description

Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.

bendamustine: 100 or 120 mg/m2 IV on days 1 and 2

erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle

Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)

All-Cause Mortality
Bendamustine and Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine and Erlotinib
Affected / at Risk (%) # Events
Total   3/11 (27.27%)    
Infections and infestations   
Infection  1  3/11 (27.27%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine and Erlotinib
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  6/11 (54.55%)  6
Cardiac disorders   
Pulmonary  1  4/11 (36.36%)  4
Gastrointestinal disorders   
Diarrhea  1  5/11 (45.45%)  5
Nausea  1  5/11 (45.45%)  5
Vomiting  1  2/11 (18.18%)  2
Mucositis  1  3/11 (27.27%)  3
General disorders   
Neutropenia  1  4/11 (36.36%)  4
Consitutional  1  7/11 (63.64%)  7
Immune system disorders   
Hypersensitivity  1  2/11 (18.18%)  2
Infections and infestations   
Infection  1  1/11 (9.09%)  1
Investigations   
Leukopenia  1  9/11 (81.82%)  9
Lymphopenia  1  11/11 (100.00%)  11
CD4 count  1  7/11 (63.64%)  7
Platelets  1  7/11 (63.64%)  7
Metabolism and nutrition disorders   
Metabolic  1  6/11 (54.55%)  6
Skin and subcutaneous tissue disorders   
Rash  1  4/11 (36.36%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachel Layman, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-366-8541
EMail: Rachel.Layman@osumc.edu
Layout table for additonal information
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00834678     History of Changes
Other Study ID Numbers: OSU-08164
NCI-2011-03164 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Submitted: January 31, 2009
First Posted: February 3, 2009
Results First Submitted: September 26, 2014
Results First Posted: April 22, 2015
Last Update Posted: April 17, 2018