Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00729612)

NCT ID: NCT00729612

Last Updated: 2018-04-02

Results Overview

Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer 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: 63 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2018-04-02

Participant Flow

Patients were enrolled in the trial between September 2008 and December 2011.

Participant milestones

Measure	Treatment (Nab-paclitaxel, Carboplatin) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	63
Overall Study Died Before Cycle 1	1
Overall Study Received Cycle 1	62
Overall Study Did Not Receive Cycle 2	7
Overall Study Received Cycle 2	54
Overall Study Died After Cycle 2 Before Response Eval	1
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Treatment (Nab-paclitaxel, Carboplatin) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Non evaluable for response	10

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. carboplatin paclitaxel albumin-stabilized nanoparticle formulation protein expression analysis immunoenzyme technique immunohistochemistry staining method laboratory biomarker analysis
Region of Enrollment United States	63 patients n=5 Participants
Age, Continuous	63.3 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer 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	Treatment (Nab-paclitaxel, Carboplatin) n=54 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria. Partial Response	38.1 percentage of patients Interval 26.1 to 51.2
Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria. Complete Response	0 percentage of patients Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 5 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Progression Free Survival	5.0 months Interval 4.3 to 6.4

SECONDARY outcome

Timeframe: Up to 5 years

Will be analyzed using a Kaplan-Meier methods.

Outcome measures

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival	9.7 months Interval 8.4 to 13.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: Grade 3 and 4

The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics

Outcome measures

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Anemia	7 patients
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Neutropenia	12 patients
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Thrombocytopenia	7 patients
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Leukopenia/lymphopenia	13 patients
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Sensory neuropathy	19 patients
Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 Fatigue	14 patients

Adverse Events

Treatment (Nab-paclitaxel, Carboplatin)

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 participants at risk Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Dehydration	1.6% 1/63 • Number of events 1 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
General disorders Death NOS	1.6% 1/63 • Number of events 1 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0

Other adverse events

Measure	Treatment (Nab-paclitaxel, Carboplatin) n=63 participants at risk Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	11.1% 7/63 • Number of events 7 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Blood and lymphatic system disorders Neutropenia	20.6% 13/63 • Number of events 13 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Blood and lymphatic system disorders Thrombocytopenia	11.1% 7/63 • Number of events 7 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Blood and lymphatic system disorders Leukopenia/Lymphopenia	20.6% 13/63 • Number of events 13 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Blood and lymphatic system disorders Febrile Neutropenia	6.3% 4/63 • Number of events 4 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Nervous system disorders Sensory Neuropathy	30.2% 19/63 • Number of events 19 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Gastrointestinal disorders Dehydration	4.8% 3/63 • Number of events 3 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
General disorders Fatigue	22.2% 14/63 • Number of events 14 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0
Metabolism and nutrition disorders Hyponatremia	6.3% 4/63 • Number of events 4 All toxicities were assessed using Common Terminology for Adverse Events (CTCAE) version 3.0

Additional Information

Gregory Otterson, MD

The Ohio State University

Phone: 614-293-2887

Email: Greg.Otterson@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place