Trial Outcomes & Findings for Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem (NCT NCT00612677)
NCT ID: NCT00612677
Last Updated: 2017-03-23
Results Overview
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
TERMINATED
PHASE2
1 participants
Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.
2017-03-23
Participant Flow
Participant milestones
| Measure |
Chemotherapy
Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Chemotherapy
Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
|
|---|---|
|
Overall Study
study closed before treatment started
|
1
|
Baseline Characteristics
Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=1 Participants
Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 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: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.Population: Study closed before treatment started.
We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.Population: Study closed before treatment started.
We planned to calculate the median Time to Progression of all participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.Population: Study closed before treatment started.
We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alberto Chiappori, M.D., via Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place