Trial Outcomes & Findings for Study of Pemetrexed and Gemcitabine for Patients With a New Diagnosis of Extensive-Stage Small Cell Lung Cancer (NCT NCT00129974)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Study Termination

Results posted on

2017-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Pemetrexed and Gemcitabine
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Pemetrexed and Gemcitabine
Overall Study Other	1

Baseline Characteristics

Study of Pemetrexed and Gemcitabine for Patients With a New Diagnosis of Extensive-Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=1 Participants Pemetrexed and Gemcitabine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Study Termination

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study Termination

Number of Participants with at least one Adverse Event

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Administration

Tufts Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place