Trial Outcomes & Findings for Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer (NCT NCT00475657)

NCT ID: NCT00475657

Last Updated: 2009-05-29

Results Overview

Trial terminated - results not analyzed

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: baseline to measured progressive disease
• Results posted on: 2009-05-29

Participant Flow

Participant milestones

Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Overall Study STARTED	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Overall Study Death	1
Overall Study Sponsor's Decision	3

Baseline Characteristics

Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Pemetrexed + Cisplatin n=5 Participants Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Age Continuous	66.6 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Spain	5 participants n=5 Participants
Race/Ethnicity Caucasian	5 participants n=5 Participants
Height	163.9 centimeters STANDARD_DEVIATION 4.2 • n=5 Participants
Weight	76.0 kilograms STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to measured progressive disease

Trial terminated - results not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to date of death from any cause

Trial terminated - results not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to measured progressive disease

Trial terminated - results not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: time of response to progressive disease

Trial terminated - results not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to measured progressive disease

Trial terminated - results not analyzed

Outcome measures

Outcome data not reported

Adverse Events

Pemetrexed + Cisplatin

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1
Renal and urinary disorders Renal failure acute	20.0% 1/5 • Number of events 1
General disorders Pyrexia	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Dysphagia	20.0% 1/5 • Number of events 1

Other adverse events

Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Number of events 1
General disorders Asthenia	20.0% 1/5 • Number of events 1
Investigations Gamma-glutamyltransferase increased	20.0% 1/5 • Number of events 1
Investigations Blood creatine increased	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Leukopenia	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Lymphopenia	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1
Endocrine disorders Inappropriate antidiuretic hormone secretion	20.0% 1/5 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 1-800-545-5979

Results disclosure agreements

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

Restriction type: GT60