Trial Outcomes & Findings for First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin (NCT NCT00316186)

Last Updated: 2015-05-07

Results Overview

The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (\>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (\>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Baseline until up to Day 169

Results posted on

2015-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Topotecan and Carboplatin Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Overall Study STARTED	33
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Intravenous Topotecan and Carboplatin Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Overall Study Adverse Event	6
Overall Study Disease Progression	4
Overall Study Lost to Follow-up	1
Overall Study Other	1

Baseline Characteristics

First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Topotecan and Carboplatin n=33 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Age, Continuous	62.2 years STANDARD_DEVIATION 9.45 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race/Ethnicity, Customized White	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until up to Day 169

Population: ITT (Intent to Treat): participants that received at least one dose of study drug

Outcome measures

Outcome measures
Measure	Intravenous Topotecan and Carboplatin n=33 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response Complete Response	0 Participants
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response Partial Response	8 Participants
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response Stable Disease	11 Participants
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response Progressive Disease	6 Participants
Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response Not Evaluable	8 Participants

SECONDARY outcome

Timeframe: From start of treatment to evidence of partial or complete response

Time to response is calculated as the time from the start of treatment until first documented evidence of partial or complete response. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of partial or complete response to disease progression/death

Duration of response is calculated as the time from first documented partial or complete response until first documented sign of disease progression or death. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to disease progression/death

Time to progression is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1 up to maximum of Day 519

Overall survival is defined as the time from the start of treatment until death due to any cause. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage of the study was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1 through Endpoint (variable based on disease progression or toxicity)

Population: ITT Population (i.e., participants who had at least one dose of study medication)

Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.

Outcome measures

Outcome measures
Measure	Intravenous Topotecan and Carboplatin n=32 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Grade 1 (Mild) Hematological Toxicities Anemia	12 participants
Grade 1 (Mild) Hematological Toxicities Neutropenia	1 participants
Grade 1 (Mild) Hematological Toxicities Thrombocytopenia	15 participants
Grade 1 (Mild) Hematological Toxicities Leukopenia	13 participants

SECONDARY outcome

Timeframe: Week 1 through Endpoint (variable based on disease progression or toxicity

Population: ITT Population (i.e., participants who had at least one dose of study medication)

Outcome measures

Outcome measures
Measure	Intravenous Topotecan and Carboplatin n=32 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Grade 2 (Moderate) Hematological Toxicities Anemia	14 participants
Grade 2 (Moderate) Hematological Toxicities Neutropenia	4 participants
Grade 2 (Moderate) Hematological Toxicities Thrombocytopenia	5 participants
Grade 2 (Moderate) Hematological Toxicities Leukopenia	10 participants

SECONDARY outcome

Timeframe: Week 1 through Endpoint (variable based on disease progression or toxicity

Population: ITT population (i.e., participants who had at least one dose of study medication)

Outcome measures

Outcome measures
Measure	Intravenous Topotecan and Carboplatin n=32 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Grade 3 (Severe) Hematological Toxicities Anemia	4 participants
Grade 3 (Severe) Hematological Toxicities Neutropenia	4 participants
Grade 3 (Severe) Hematological Toxicities Thrombocytopenia	2 participants
Grade 3 (Severe) Hematological Toxicities Leukopenia	4 participants

SECONDARY outcome

Timeframe: Week 1 through Endpoint (variable based on disease progression or toxicity

Population: ITT population (i.e., participants who had at least one dose of study medication)

Outcome measures

Outcome measures
Measure	Intravenous Topotecan and Carboplatin n=32 Participants Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Grade 4 (Life-threatening or Disabling) Hematological Toxicities Anemia	2 participants
Grade 4 (Life-threatening or Disabling) Hematological Toxicities Neutropenia	4 participants
Grade 4 (Life-threatening or Disabling) Hematological Toxicities Thrombocytopenia	2 participants
Grade 4 (Life-threatening or Disabling) Hematological Toxicities Leukopenia	0 participants

Adverse Events

Intravenous Topotecan and Carboplatin

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intravenous Topotecan and Carboplatin n=33 participants at risk Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Gastrointestinal disorders Gastro-intestinal hemorrhage	3.0% 1/33
Blood and lymphatic system disorders Anemia	3.0% 1/33
Nervous system disorders Brain Mass	3.0% 1/33
Respiratory, thoracic and mediastinal disorders Pneumonia	3.0% 1/33
General disorders Pyrexia	3.0% 1/33
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.0% 1/33
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	3.0% 1/33
General disorders Diease under study	3.0% 1/33

Other adverse events

Other adverse events
Measure	Intravenous Topotecan and Carboplatin n=33 participants at risk Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
Blood and lymphatic system disorders Anemia	36.4% 12/33
Blood and lymphatic system disorders Neutropenia	42.4% 14/33
Blood and lymphatic system disorders Thrombocytopenia	39.4% 13/33
Blood and lymphatic system disorders Leukopenia	6.1% 2/33
General disorders Fatigue	18.2% 6/33
Gastrointestinal disorders Nausea	15.2% 5/33
Gastrointestinal disorders Constipation	12.1% 4/33
Respiratory, thoracic and mediastinal disorders Chest Pain	12.1% 4/33
Infections and infestations Mucosal inflammation	9.1% 3/33
Gastrointestinal disorders Vomiting	9.1% 3/33
Nervous system disorders Neuropathy peripheral	9.1% 3/33
General disorders Pyrexia	6.1% 2/33
Gastrointestinal disorders Abdominal Pain	6.1% 2/33
Respiratory, thoracic and mediastinal disorders Cough	6.1% 2/33
Cardiac disorders Dyspnea	6.1% 2/33
Cardiac disorders Dyspnea exertional	6.1% 2/33
Respiratory, thoracic and mediastinal disorders Productive cough	6.1% 2/33
Metabolism and nutrition disorders Hyperuricemia	6.1% 2/33
Metabolism and nutrition disorders Hypokalemia	6.1% 2/33
Skin and subcutaneous tissue disorders Pruritus	6.1% 2/33
Skin and subcutaneous tissue disorders Rash	6.1% 2/33
General disorders Back Pain	6.1% 2/33
Psychiatric disorders Insomnia	6.1% 2/33
Eye disorders Vision Blurred	6.1% 2/33

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER