Trial Outcomes & Findings for Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Recurrent Advanced Non-Small Cell Lung Cancer (NCT NCT00728845)
NCT ID: NCT00728845
Last Updated: 2017-05-23
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Followed for the duration of the phase 1 treatment, an average of 18 weeks
Results posted on
2017-05-23
Participant Flow
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and the Robert Wood Johnson University Hospital-Hamilton in New Jersey from June 2008 through December 2010.
Participant milestones
| Measure |
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
Hydroxychloroquine, Carboplatin, Paclitaxel
Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
|
Overall Study
COMPLETED
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Recurrent Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
n=8 Participants
Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
Hydroxychloroquine, Carboplatin, Paclitaxel
Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
—
|
63.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
—
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Followed for the duration of the phase 1 treatment, an average of 18 weeksPopulation: Study was terminated early and insufficient data were collected to assess this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Treatment start date to date of best responsePopulation: Study was terminated early and insufficient data were collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Treatment start date and date of progressionPopulation: Study was terminated early and insufficient data were collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Treatment start date to 1 yearPopulation: Study was terminated early and insufficient data were collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Treatment start date to date of deathPopulation: Study was terminated early and insufficient data were collected to assess this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Hydroxychloroquine, Carboplatin, Paclitaxel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
n=8 participants at risk
Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
Hydroxychloroquine, Carboplatin, Paclitaxel
Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
|---|---|---|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
Other adverse events
| Measure |
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
n=8 participants at risk
Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
Hydroxychloroquine, Carboplatin, Paclitaxel
Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
87.5%
7/8 • Number of events 13 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
75.0%
6/8 • Number of events 15 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
62.5%
5/8 • Number of events 9 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Platelets
|
50.0%
4/8 • Number of events 8 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
4/8 • Number of events 5 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Number of events 4 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Anorexia
|
37.5%
3/8 • Number of events 4 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
37.5%
3/8 • Number of events 5 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 5 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Nervous system disorders
Neuropathy: sensory
|
87.5%
7/8 • Number of events 16 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Nervous system disorders
Syncope (fainting)
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Psychiatric disorders
Mood alteration - Depression
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Psychiatric disorders
Neuropathy: motor
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
62.5%
5/8 • Number of events 7 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
37.5%
3/8 • Number of events 3 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Extremity-limb
|
37.5%
3/8 • Number of events 5 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Abdomen NOS
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Bone
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Chest wall
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Chest/thorax NOS
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Back
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Buttock
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Dental/teeth/peridontal
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Head/headache
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Joint
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Oral cavity
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Pain - Stomach
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
4/8 • Number of events 5 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
50.0%
4/8 • Number of events 4 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
75.0%
6/8 • Number of events 8 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Weight loss
|
62.5%
5/8 • Number of events 7 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
37.5%
3/8 • Number of events 3 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Insomnia
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Rigors/chills
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
37.5%
3/8 • Number of events 3 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
37.5%
3/8 • Number of events 4 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Alkaline phosphatase
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Metabolic/Laboratory - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Cardiac disorders
Hypertension
|
62.5%
5/8 • Number of events 10 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
37.5%
3/8 • Number of events 4 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
General disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage, GI - Upper GI NOS
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage, GU - Bladder
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Infections and infestations
Infection - Other (Specify, __)
|
25.0%
2/8 • Number of events 2 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Eye disorders
Cataract
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Vascular disorders
Edema: limb
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
12.5%
1/8 • Number of events 1 • 2 years and 6 months
|
—
0/0 • 2 years and 6 months
|
Additional Information
Dr. Joseph Aisner
Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place