Trial Outcomes & Findings for Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC) (NCT NCT00240097)

Results Overview

The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

baseline to 18 months

Results posted on

2014-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen A and B Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Part I STARTED	30
Part I COMPLETED	26
Part I NOT COMPLETED	4
Part II STARTED	26
Part II COMPLETED	3
Part II NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen A and B Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Part I Adverse Event	1
Part I Death	1
Part I histology	1
Part I unevaluable	1
Part II did not continue from Part I	23

Baseline Characteristics

Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A and B n=30 Participants Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 18 months

The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.

Outcome measures

Outcome measures
Measure	Regimen A and B n=26 Participants Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
Objective Response Rate (Part I) Complete response	4 Participants
Objective Response Rate (Part I) Partial response	20 Participants
Objective Response Rate (Part I) Stable disease	1 Participants
Objective Response Rate (Part I) Progressive disease	0 Participants
Objective Response Rate (Part I) Unevaluable	1 Participants

PRIMARY outcome

Timeframe: 3 weeks after 3rd cycle of starting therapy after relapse or refractory disease

Population: All subjects dropped out or died prior to experiencing relapse

The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to five years

Time to progressive disease

Outcome measures

Outcome measures
Measure	Regimen A and B n=26 Participants Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
Progression Free Survival (Part I)	8.95 months Interval 6.5 to 9.8

SECONDARY outcome

Timeframe: baseline to 2 years

Length of subject survival after starting study treatment

Outcome measures

Outcome measures
Measure	Regimen A and B n=26 Participants Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
Overall Survival (Part I)	12.9 months Interval 10.2 to 15.5

Adverse Events

Regimen A First Cycle

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Regimen B First Cycle

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Regimen A Overall Toxicity

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Regimen B Overall Toxicity

Serious events: 19 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Regimen A First Cycle n=26 participants at risk Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)	Regimen B First Cycle n=26 participants at risk Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)	Regimen A Overall Toxicity n=26 participants at risk Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)	Regimen B Overall Toxicity n=26 participants at risk Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Blood and lymphatic system disorders Grade 3 Thrombocytopenia	11.5% 3/26 • Number of events 3	11.5% 3/26 • Number of events 3	7.7% 2/26 • Number of events 2	73.1% 19/26 • Number of events 24
Blood and lymphatic system disorders Grade 4 Thrombocytopenia	0.00% 0/26	19.2% 5/26 • Number of events 5	0.00% 0/26	57.7% 15/26 • Number of events 22
Blood and lymphatic system disorders Grade 3 Anemia	0.00% 0/26	3.8% 1/26 • Number of events 1	3.8% 1/26 • Number of events 1	26.9% 7/26 • Number of events 9
Gastrointestinal disorders Grade 3 nausea and vomiting	3.8% 1/26 • Number of events 1	0.00% 0/26	7.7% 2/26 • Number of events 2	0.00% 0/26
Gastrointestinal disorders Grade 3 diarrhea	11.5% 3/26 • Number of events 3	0.00% 0/26	19.2% 5/26 • Number of events 6	0.00% 0/26
General disorders Grade 3 Fatigue	3.8% 1/26 • Number of events 1	3.8% 1/26 • Number of events 1	19.2% 5/26 • Number of events 6	7.7% 2/26 • Number of events 2
Blood and lymphatic system disorders Grade 3 Neutropenia	7.7% 2/26 • Number of events 2	3.8% 1/26 • Number of events 1	11.5% 3/26 • Number of events 4	3.8% 1/26 • Number of events 1
Blood and lymphatic system disorders Grade 4 Neutropenia	3.8% 1/26 • Number of events 1	23.1% 6/26 • Number of events 6	7.7% 2/26 • Number of events 3	23.1% 6/26 • Number of events 8

Other adverse events

Other adverse events
Measure	Regimen A First Cycle n=26 participants at risk Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)	Regimen B First Cycle n=26 participants at risk Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)	Regimen A Overall Toxicity n=26 participants at risk Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)	Regimen B Overall Toxicity n=26 participants at risk Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
Gastrointestinal disorders nausea and vomiting	15.4% 4/26 • Number of events 4	0.00% 0/26	46.2% 12/26 • Number of events 16	3.8% 1/26 • Number of events 1
Gastrointestinal disorders Diarrhea	11.5% 3/26 • Number of events 3	0.00% 0/26	26.9% 7/26 • Number of events 9	3.8% 1/26 • Number of events 1
General disorders Fatigue	26.9% 7/26 • Number of events 7	23.1% 6/26 • Number of events 6	76.9% 20/26 • Number of events 29	50.0% 13/26 • Number of events 22

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