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S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib

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ClinicalTrials.gov Identifier: NCT02134912
Recruitment Status : Terminated (science has moved forward and there is no intent to complete the study)
First Posted : May 9, 2014
Results First Posted : May 1, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Lung
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions Drug: crizotinib
Drug: pemetrexed disodium
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 1
Recruitment Details  
Pre-assignment Details There is only one patient enrolled in this study. Patient was taken off study treatment by treating physician due to recent changes in standard of care. And patient never started protocol treatment. Thus we didn't enter any results for this only patient in the trial.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium) Total
Hide Arm/Group Description

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy
Hide Description A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms.
Time Frame From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Incidence of Adverse Events of Crizotinib in Combination With Pemetrexed Disodium, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Comparisons of toxicities rates will be done using a Fisher's exact or chi-squared test of independence, when appropriate using 10% as the significance threshold. Within each treatment arm, any toxicity with at least 5% prevalence has at least a 95% chance of being observed.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy
Hide Description Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium
Hide Description Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Patterns of Failure
Hide Description Defined as CNS-only, extra-CNS, and both CNS and extra-CNS progression between the treatment arms. Evaluated within each treatment arm using cumulative incidence curves.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall Survival
Hide Description Differences in OS by treatment arm will be evaluated using a 1-sided log-rank test with significant level of 10%.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description:

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 3 years
Adverse Event Reporting Description The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
 
Arm/Group Title Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Hide Arm/Group Description

Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.

crizotinib: Given PO

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

pemetrexed disodium: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

All-Cause Mortality
Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Crizotinib, Pemetrexed Disodium) Arm II (Pemetrexed Disodium)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melanoma Statistician
Organization: SWOG
Phone: 2066674623
EMail: jmoon@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02134912    
Other Study ID Numbers: S1300
NCI-2014-00685 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1300 ( Other Identifier: SWOG )
S1300 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: April 11, 2019
Results First Posted: May 1, 2019
Last Update Posted: February 20, 2020