Trial Outcomes & Findings for Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer (NCT NCT00259285)

Last Updated: 2009-06-02

Results Overview

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

every 21 day cycle (3 cycles) and 3-4 weeks after last cycle

Results posted on

2009-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemetrexed + Cisplatin n=10 Participants Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Age Continuous	61.6 years STANDARD_DEVIATION 8.2 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Region of Enrollment Spain	10 participants n=99 Participants
Eastern Cooperative Oncology Group Functional Status 0 - Fully Active	8 participants n=99 Participants
Eastern Cooperative Oncology Group Functional Status 1 - Ambulatory, Restricted Strenuous Activity	2 participants n=99 Participants
Eastern Cooperative Oncology Group Functional Status 2 - Ambulatory, No Work Activities	0 participants n=99 Participants
Eastern Cooperative Oncology Group Functional Status 3 - Partially Confined to Bed, Limited Self Care	0 participants n=99 Participants
Eastern Cooperative Oncology Group Functional Status 4 - Completely Disabled	0 participants n=99 Participants
Race/Ethnicity Caucasian	10 participants n=99 Participants
Body Mass Index	27.1 kilograms per square meters STANDARD_DEVIATION 4.3 • n=99 Participants
Corporal Surface (Body Surface Area)	1.8 square meters STANDARD_DEVIATION 0.2 • n=99 Participants
Height	1.6 meters STANDARD_DEVIATION 0.1 • n=99 Participants
Weight	72.8 kilograms STANDARD_DEVIATION 12.2 • n=99 Participants

PRIMARY outcome

Timeframe: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle

Outcome measures

Outcome measures
Measure	Pemetrexed + Cisplatin n=10 Participants Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Treatment Response Complete Response	0 participants
Treatment Response Partial Response	5 participants
Treatment Response Incomplete Response/Stable Disease	4 participants
Treatment Response Progressive Disease	1 participants
Treatment Response Not Evaluable	0 participants

SECONDARY outcome

Timeframe: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)

Population: 7 out of the 10 patients had surgery.

The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.

Outcome measures

Outcome measures
Measure	Pemetrexed + Cisplatin n=7 Participants Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Pathologic Remissions After Surgery Complete Remission - Yes	5 participants
Pathologic Remissions After Surgery Complete Remission - No	2 participants

SECONDARY outcome

Timeframe: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter

Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.

Outcome measures

Outcome data not reported

Adverse Events

Pemetrexed + Cisplatin

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Infections and infestations Urinary tract infection	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Blood and lymphatic system disorders Leukocytosis	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders Leukopenia	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders Neutrophilia	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Abdominal Distension	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Nausea	40.0% 4/10 • Number of events 5
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 2
General disorders Fatigue	10.0% 1/10 • Number of events 1
General disorders Mucosal inflammation	10.0% 1/10 • Number of events 1
General disorders Pyrexia	10.0% 1/10 • Number of events 2
Infections and infestations Candidiasis	10.0% 1/10 • Number of events 1
Infections and infestations Respiratory tract infection	10.0% 1/10 • Number of events 1
Investigations Alanine aminotransferase increased	20.0% 2/10 • Number of events 2
Investigations Aspartate aminotransferase increased	20.0% 2/10 • Number of events 2
Investigations Haemoglobin decreased	10.0% 1/10 • Number of events 1
Investigations Platelet count increased	10.0% 1/10 • Number of events 1
Metabolism and nutrition disorders Diabetes mellitus	10.0% 1/10 • Number of events 1
Nervous system disorders Motor dysfunction	10.0% 1/10 • Number of events 1
Nervous system disorders Paraesthesia	10.0% 1/10 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	30.0% 3/10 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dysphonia	10.0% 1/10 • Number of events 1
Respiratory, thoracic and mediastinal disorders Productive cough	10.0% 1/10 • Number of events 1
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Number of events 1
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Number of events 2
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	10.0% 1/10 • 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