Trial Outcomes & Findings for BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00411632)
NCT ID: NCT00411632
Last Updated: 2020-01-29
Results Overview
The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progression or death from any cause. OS was assessed from the date of randomization until death from any cause. Tumor response was assessed every 8 weeks until disease progression. Toxicity was assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
COMPLETED
PHASE2
37 participants
8 weeks
2020-01-29
Participant Flow
Thirty-seven (37) patients were registered into this trial. All thirty-seven (37) patients were eligible to participate in this trial.
Participants enrolling in this study must first be enrolled in the BATTLE umbrella protocol and must meet all of the BATTLE eligibility criteria. Participants enrolled in the BATTLE program will be assigned to a specific biomarker-integrated study based on the adaptive randomization model.
Participant milestones
| Measure |
Erlotinib + Bexatrtene
Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days
Erlotinib: 150 mg by mouth daily x 28 Days
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Erlotinib + Bexatrtene
Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days
Erlotinib: 150 mg by mouth daily x 28 Days
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Bexarotene + Erlotinib
n=37 Participants
Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days
Erlotinib: 150 mg by mouth daily x 28 Days
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Age, Customized
<=50 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
51-60 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
61-70 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
>70 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The primary end point was the 8-week DCR \[complete or partial response or stable disease via Response Evaluation Criteria in Solid Tumors (RECIST, which we compared with the historical 30% DCR estimate in similar patients. Treatment efficacy (a positive finding) was defined as \>0.80 probability of achieving\>30% DCR.
The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progression or death from any cause. OS was assessed from the date of randomization until death from any cause. Tumor response was assessed every 8 weeks until disease progression. Toxicity was assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Outcome measures
| Measure |
Erlotinib + Bexatrtene
n=37 Participants
Erlotinib 150 mg by mouth daily + bexarotene 400 mg/m2/day daily (1 cycle =4 weeks) for 2 cycles, tumor response will be evaluated at the end of the second cycle. Patients who have progressed stop treatment and can renter the main BATTLE protocol and be assigned to another Phase II trial.
|
|---|---|
|
Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
EGFR
|
11 participants
|
|
Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
KRAS/BRAF
|
1 participants
|
|
Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
VEGF/VEGFR-2
|
0 participants
|
|
Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
RXR/Cyclin D1
|
1 participants
|
|
Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
None
|
5 participants
|
Adverse Events
Erlotinib + Bexatrtene
Serious adverse events
| Measure |
Erlotinib + Bexatrtene
n=37 participants at risk
Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days
Erlotinib: 150 mg by mouth daily x 28 Days
|
|---|---|
|
Metabolism and nutrition disorders
Hypertriglyceridema
|
10.8%
4/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Investigations
Lipase increased
|
2.7%
1/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Investigations
Fatigue
|
16.2%
6/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Investigations
INR
|
5.4%
2/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
Other adverse events
| Measure |
Erlotinib + Bexatrtene
n=37 participants at risk
Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days
Erlotinib: 150 mg by mouth daily x 28 Days
|
|---|---|
|
Metabolism and nutrition disorders
Hypertriglceridemia
|
21.6%
8/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.4%
2/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
8.1%
3/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
24.3%
9/37 • January 1, 2007 to November 24, 2009 Participants were assessed for response until progression and for survival up to 3 years following completion of study treatment.
|
Additional Information
Dr. John V Heymach, PHD/ Chair, Thoracic-Head & Neck Med Onc
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place