Trial Outcomes & Findings for Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II (NCT NCT01649947)
NCT ID: NCT01649947
Last Updated: 2022-11-21
Results Overview
Assessed using RECIST criteria. Determined using a Simon's two-stage minimax design with a 5% significance level and 80% power.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
6 years
Results posted on
2022-11-21
Participant Flow
Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 12/23/2011 and closed to accrual on 06/30/2015.
We are reporting results on 32 eligible patients. Seven patients were deemed ineligible.
Participant milestones
| Measure |
Cohort 1: Bevacizumab Eligible Patients
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a
|
Cohort 2: Bevacizumab Ineligible Patients
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
20
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II
Baseline characteristics by cohort
| Measure |
Cohort 1: Bevacizumab Eligible Patients
n=12 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a
|
Cohort 2: Bevacizumab Ineligible Patients
n=20 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
20 participants
n=4 Participants
|
32 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: The analysis is comprise of evaluable patients who had measurable disease and received at least one cycle of therapy and had disease evaluated.
Assessed using RECIST criteria. Determined using a Simon's two-stage minimax design with a 5% significance level and 80% power.
Outcome measures
| Measure |
Cohort 2: Bevacizumab Ineligible Patients
n=11 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily)
|
Cohort 1: Bevacizumab Eligible Patients
n=15 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine 600 mg BID
|
|---|---|---|
|
Antitumor Activity, as Measured by Tumor Response Rate of Hydroxychloroquine, Paclitaxel, Carboplatin, and Bevacizumab (for Eligible Patients) in Patients With Advanced or Recurrent NSCLC Cancer
|
55 percentage of participants
Interval 23.4 to 83.0
|
27 percentage of participants
Interval 7.8 to 55.1
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Median PFS (in months) were calculated
Kaplan-Meier estimates of survival were calculated. The median survival times and 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 2: Bevacizumab Ineligible Patients
n=11 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily)
|
Cohort 1: Bevacizumab Eligible Patients
n=15 Participants
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
Paclitaxel: Paclitaxel was given at a dose of 200 mg/m2(by IV over 3 hours on Day 1).
Cycles every 3 weeks for 4-6 Cycles.
Prior to receiving paclitaxel, all patients will receive the following premedication:
* Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
* Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion
* Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Carboplatin: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine: Hydroxychloroquine 600 mg BID
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.2 months
Interval 1.8 to 6.4
|
2.9 months
Interval 2.0 to 4.6
|
Adverse Events
Cohort 1: Bevacizumab Eligible Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Bevacizumab Ineligible Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joseph Aisner, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-7401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place