Trial Outcomes & Findings for Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers (NCT NCT02525653)
NCT ID: NCT02525653
Last Updated: 2021-01-12
Results Overview
defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
1 year
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Baseline characteristics by cohort
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
n=40 Participants
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
2 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
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yeardefined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. 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
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
n=40 Participants
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Overall Response Rate
Partial Response
|
18 Participants
|
|
Overall Response Rate
Complete Response
|
1 Participants
|
|
Overall Response Rate
Not Evaluated, withdrew from study
|
5 Participants
|
|
Overall Response Rate
Stable Disease
|
12 Participants
|
|
Overall Response Rate
No Response
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearAE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics.
Outcome measures
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
n=40 Participants
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Participants Evaluated for Toxicity
Evaluable for toxicity
|
37 Participants
|
|
Participants Evaluated for Toxicity
Not evaluable for toxicity
|
3 Participants
|
Adverse Events
Albumin-Bound Paclitaxel and Gemcitabine
Serious events: 7 serious events
Other events: 37 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
n=40 participants at risk
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.0%
2/40 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.5%
1/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • 1 year
|
|
Investigations
Creatinine increased
|
5.0%
2/40 • 1 year
|
|
General disorders
Death NOS
|
15.0%
6/40 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • 1 year
|
|
General disorders
Edema limbs
|
2.5%
1/40 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
2/40 • 1 year
|
|
General disorders
Fever
|
7.5%
3/40 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.5%
1/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Hypotension
|
10.0%
4/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.5%
1/40 • 1 year
|
|
Infections and infestations
Lung infection
|
12.5%
5/40 • 1 year
|
|
Infections and infestations
Mucosal Infection
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.5%
1/40 • 1 year
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.5%
3/40 • 1 year
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • 1 year
|
|
Infections and infestations
Skin infection
|
5.0%
2/40 • 1 year
|
|
General disorders
Sudden death NOS
|
2.5%
1/40 • 1 year
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.5%
1/40 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Transient ischemic attacks
|
2.5%
1/40 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • 1 year
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.5%
1/40 • 1 year
|
|
Investigations
White blood cell decreased
|
2.5%
1/40 • 1 year
|
Other adverse events
| Measure |
Albumin-Bound Paclitaxel and Gemcitabine
n=40 participants at risk
During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
5/40 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
70.0%
28/40 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
27.5%
11/40 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
92.5%
37/40 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
62.5%
25/40 • 1 year
|
|
Investigations
Blood bilirubin increased
|
17.5%
7/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • 1 year
|
|
Investigations
Creatinine increased
|
17.5%
7/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • 1 year
|
|
General disorders
Fatigue
|
10.0%
4/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
4/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
92.5%
37/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
30.0%
12/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hypernatremia
|
15.0%
6/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
87.5%
35/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
47.5%
19/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
4/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
6/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.5%
9/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
16/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
2/40 • 1 year
|
|
Investigations
INR increased
|
32.5%
13/40 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
60.0%
24/40 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • 1 year
|
|
Investigations
Neutrophil count decreased
|
37.5%
15/40 • 1 year
|
|
Investigations
Platelet count decreased
|
62.5%
25/40 • 1 year
|
|
Investigations
White blood cell decreased
|
62.5%
25/40 • 1 year
|
Additional Information
Dr. Paul Paik, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place