Trial Outcomes & Findings for Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer (NCT NCT00834678)

NCT ID: NCT00834678

Last Updated: 2018-04-17

Results Overview

28 day cycle included intravenous bendamustine on days 1 and 2.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to two years

Results posted on

2018-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bendamustine and Erlotinib 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 Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bendamustine and Erlotinib n=11 Participants 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)
Age, Continuous	53 years n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	11 participants n=99 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 0 (Fully active)	4 participants n=99 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 1 (Restricted)	6 participants n=99 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 2 (Ambulatory and capable selfcare)	1 participants n=99 Participants
Site of metastasis Lymph nodes	9 participants n=99 Participants
Site of metastasis Lung/pleura	6 participants n=99 Participants
Site of metastasis Bone	4 participants n=99 Participants
Site of metastasis Liver	3 participants n=99 Participants
Site of metastasis Chest wall/skin	3 participants n=99 Participants
Site of metastasis Brain	1 participants n=99 Participants
Prior chemotherapy Adjuvant only	4 participants n=99 Participants
Prior chemotherapy Metastasis/local recurrence only	1 participants n=99 Participants
Prior chemotherapy Both	6 participants n=99 Participants
Total number of prior treatment regimens 1 prior regimen	4 participants n=99 Participants
Total number of prior treatment regimens 2 prior regimens	7 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to two years

28 day cycle included intravenous bendamustine on days 1 and 2.

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)	120 mg/m^2

PRIMARY outcome

Timeframe: Up to two years

28 day cycle included intravenous erlotinib on days 15-21.

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)	150 mg

PRIMARY outcome

Timeframe: Up to two years

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Dose-limiting Toxicity (Phase I) Dose level I, n=5	0 patients
Dose-limiting Toxicity (Phase I) Dose level II, n=6	1 patients

PRIMARY outcome

Timeframe: Up to two years

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

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Progression-free Survival at 6 Months and 12 Months (Phase II)	3.7 months Interval 1.7 to 5.5

SECONDARY outcome

Timeframe: Up to two years

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.

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Objective Response Rate (ORR) Dose Level 1	0 patients
Objective Response Rate (ORR) Dose Level 2	1 patients

SECONDARY outcome

Timeframe: Up to two years

Population: The data was not collected and analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to two years

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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.
Duration of Response (DR)	3.7 months to progression Interval 1.7 to 5.5

SECONDARY outcome

Timeframe: from time of study enrollment until death, for up to 2 years

Outcome measures

Outcome measures
Measure	Bendamustine and Erlotinib n=11 Participants 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 Survival (OS)	10.8 months Interval 3.6 to 13.1

SECONDARY outcome

Timeframe: up to two years

Population: Correlative studies to assess EGFR expression and gene amplification, were planned, but not collected because of early trial termination.

Outcome measures

Outcome data not reported

Adverse Events

Bendamustine and Erlotinib

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bendamustine and Erlotinib n=11 participants at risk 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)
Infections and infestations Infection	27.3% 3/11 • Number of events 3 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.

Other adverse events

Other adverse events
Measure	Bendamustine and Erlotinib n=11 participants at risk 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)
Investigations Leukopenia	81.8% 9/11 • Number of events 9 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
General disorders Neutropenia	36.4% 4/11 • Number of events 4 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Investigations Lymphopenia	100.0% 11/11 • Number of events 11 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Investigations CD4 count	63.6% 7/11 • Number of events 7 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Blood and lymphatic system disorders Hemoglobin	54.5% 6/11 • Number of events 6 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Investigations Platelets	63.6% 7/11 • Number of events 7 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Immune system disorders Hypersensitivity	18.2% 2/11 • Number of events 2 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Skin and subcutaneous tissue disorders Rash	36.4% 4/11 • Number of events 4 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Gastrointestinal disorders Diarrhea	45.5% 5/11 • Number of events 5 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Gastrointestinal disorders Nausea	45.5% 5/11 • Number of events 5 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Gastrointestinal disorders Vomiting	18.2% 2/11 • Number of events 2 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Gastrointestinal disorders Mucositis	27.3% 3/11 • Number of events 3 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
General disorders Consitutional	63.6% 7/11 • Number of events 7 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Metabolism and nutrition disorders Metabolic	54.5% 6/11 • Number of events 6 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Cardiac disorders Pulmonary	36.4% 4/11 • Number of events 4 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.
Infections and infestations Infection	9.1% 1/11 • Number of events 1 • Adverse events were collected from beginning of cycle 1 treatment through end of treatment, for up to 2 years This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0 for toxicity and Serious Adverse Event reporting.

Additional Information

Rachel Layman, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-366-8541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place