Trial Outcomes & Findings for Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy (NCT NCT02303977)

Last Updated: 2021-09-29

Results Overview

The percentage of patients with a Partial Response or Complete Response recorded from the start of the treatment until disease progression/recurrence by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Averaging about 16 weeks.

Results posted on

2021-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine + Paciltaxel All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine + Paciltaxel n=37 Participants All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=37 Participants
Age, Categorical >=65 years	20 Participants n=37 Participants
Age, Continuous	66 years n=37 Participants
Sex: Female, Male Female	22 Participants n=37 Participants
Sex: Female, Male Male	15 Participants n=37 Participants
Region of Enrollment United States	37 participants n=37 Participants

PRIMARY outcome

Timeframe: Averaging about 16 weeks.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paciltaxel n=37 Participants All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Overall Response Rate	13.5 percentage of participants Interval 2.5 to 24.5

SECONDARY outcome

Timeframe: Averaging about 16 weeks

Measures the length of time from the first day of therapy until Progressive Disease, death from any cause, or last patient contact. Disease Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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	Gemcitabine + Paciltaxel n=37 Participants All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Progression-free Survival	2.6 Months Interval 1.4 to 3.8

SECONDARY outcome

Timeframe: Averaging about 47 weeks

Length of time from the first day of therapy to death from any cause or last patient contact

Outcome measures

Outcome measures
Measure	Gemcitabine + Paciltaxel n=37 Participants All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Overall Survival	6.2 Months Interval 4.2 to 8.2

SECONDARY outcome

Timeframe: The duration of study treatment, averaging about 16 weeks.

The percentage of patients with a Partial Response, a Complete Response, or Stable Disease during the study. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paciltaxel n=37 Participants All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Disease Control Rate	59.5 Percentage of participants Interval 43.5 to 75.5

Adverse Events

Gemcitabine + Paciltaxel

Serious events: 22 serious events

Other events: 34 other events

Deaths: 36 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine + Paciltaxel n=37 participants at risk All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
Gastrointestinal disorders Vomitting	10.8% 4/37 • Number of events 4 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Infections and infestations Lung Infection	13.5% 5/37 • Number of events 5 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Nervous system disorders Myelitis	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Infections and infestations Sepsis	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Nausea	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Vascular disorders thromboembolic event	18.9% 7/37 • Number of events 7 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Blood and lymphatic system disorders anemia	8.1% 3/37 • Number of events 3 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Infections and infestations ANC Decreased	10.8% 4/37 • Number of events 4 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
General disorders Failure to thrive	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Infections and infestations WBC decreased	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Metabolism and nutrition disorders Hyponatremia	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Metabolism and nutrition disorders Hyperglycemia	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Infections and infestations Soft Tissue Infection	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Nervous system disorders Tumor invasion of left brachial plexus	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.4% 2/37 • Number of events 2 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 1/37 • Number of events 1 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.

Other adverse events

Other adverse events
Measure	Gemcitabine + Paciltaxel n=37 participants at risk All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.
General disorders Fatigue	51.4% 19/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Blood and lymphatic system disorders Anemia	45.9% 17/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Nausea	32.4% 12/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Skin and subcutaneous tissue disorders Alopecia	29.7% 11/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Investigations Neutrophil count decreased	27.0% 10/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Metabolism and nutrition disorders Anorexia	24.3% 9/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Diarrhea	18.9% 7/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
General disorders Fever	18.9% 7/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Vomitting	18.9% 7/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Investigations Platelet count decreased	16.2% 6/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Investigations ALT increased	13.5% 5/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Nervous system disorders Neuropathy	13.5% 5/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Skin and subcutaneous tissue disorders Rash	13.5% 5/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Blood and lymphatic system disorders White blood cell decreased	13.5% 5/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Investigations AST Increased	10.8% 4/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Gastrointestinal disorders Constipation	10.8% 4/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.
Musculoskeletal and connective tissue disorders Myalgia	10.8% 4/37 • Adverse events were assessed from the time of the initiation of study treatment, until 30 days after the end of study treatment, for an average of about 20 weeks. All-Cause Mortality was assessed from the time of study initiation until the death of the subject by any cause, up to approximately 47 weeks.

Additional Information

Dr. Christine Ciunci

Abramson Cancer Center, Penn Presbyterian Medical Center

Phone: 215-662-9801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place