Trial Outcomes & Findings for Study of Low Dose Chemotherapy Plus Sorafenib as Initial Therapy for Patients With Advanced Non-Squamous Cell NSCLC (NCT NCT00801801)

Results Overview

Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%. The 2-month progression free survival is determined after 8 weeks on treatment. Those patients that had less than 20% increase in the tumor target lesions are considered as progression free survival. The primary endpoint is the percentage of patients that are progression free in 2 months.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline to 2 months

Results posted on

2017-05-17

Participant Flow

Protocol Open to Accrual: January 2008, Primary Completion Date: October 2009 and Study Completion Date: March 2011. Recruitment location: University of Alabama at Birmingham.

This study is to evaluate the use of targeted therapy as well as low dose-protracted chemotherapy (metronomic chemotherapy) in patients with advanced or metastatic non-squamous cell lung cancer (NSCLC). There is an increased need for better strategies to improve survival as well as reduce regimen related toxicities for this large group of patients.

Participant milestones

Participant milestones
Measure	Metronomic Taxotere and Nexavar Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy. Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Dose Chemotherapy Plus Sorafenib as Initial Therapy for Patients With Advanced Non-Squamous Cell NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metronomic Taxotere + Nexavar n=5 Participants Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 12.62 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 months

Population: As the study did not accrue the maximum sample size for statistical analysis, none were done.

Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%. The 2-month progression free survival is determined after 8 weeks on treatment. Those patients that had less than 20% increase in the tumor target lesions are considered as progression free survival. The primary endpoint is the percentage of patients that are progression free in 2 months.

Outcome measures

Outcome measures
Measure	Metronomic Taxotere + Nexavar n=5 Participants Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
2-month Progression-free Survival Rate	4 participants

SECONDARY outcome

Timeframe: 6 months

To assess response rate and tumor control rate (complete remission + partial remission + stable disease) in poor performance status (PS =2) patients with advanced or metastatic (Stage IIIB - pleural effusion/IV) non-squamous cell-NSCLC treated with metronomic chemotherapy plus sorafenib. The objective response was defined as a percentage of those patients that had 30% or more of tumor regression at any time during treatment. Tumor control rate include the percentage of those patients that have less than 20% increase in the target tumor parameters during treatment (stable disease + partial response + complete response).

Outcome measures

Outcome measures
Measure	Metronomic Taxotere + Nexavar n=5 Participants Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
Response Rate in Poor Performance Status Subjects	0 participants

Adverse Events

Metronomic Taxotere and Nexavar

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Metronomic Taxotere and Nexavar n=5 participants at risk Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
Cardiac disorders Pulmonary Embolism	40.0% 2/5 • Number of events 2 • Toxicity assessment was performed on a weekly up to 6 months.
Cardiac disorders Atrial Fibrillation	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.
Vascular disorders Stroke	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.

Other adverse events

Other adverse events
Measure	Metronomic Taxotere and Nexavar n=5 participants at risk Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
General disorders Fatigue	40.0% 2/5 • Number of events 2 • Toxicity assessment was performed on a weekly up to 6 months.
Gastrointestinal disorders Nausea & Vomiting	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.
Hepatobiliary disorders Hyperbilirubenemia	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.
Hepatobiliary disorders Transaminases	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.
Metabolism and nutrition disorders Hyperkalemia	20.0% 1/5 • Number of events 1 • Toxicity assessment was performed on a weekly up to 6 months.

Additional Information

Dr. Francisco Robert

UAB

Phone: 205-934-5077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place