Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01664754|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2012
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Non-small Cell Lung Cancer||Drug: exemestane Drug: pemetrexed disodium Drug: carboplatin Other: laboratory biomarker analysis Other: pharmacological study Other: questionnaire administration Procedure: quality-of-life assessment||Phase 1|
I. Evaluate the safety and tolerability of escalating doses of exemestane when given with pemetrexed (pemetrexed disodium) and carboplatin in post-menopausal women with stage IV non-squamous, non-small cell lung cancer (NSCLC).
I. Determine the objective tumor response rate (defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in patients treated with pemetrexed, carboplatin and exemestane.
II. Evaluate the pharmacokinetic profile of pemetrexed, carboplatin and exemestane.
III. Evaluate quality of life in patients treated with pemetrexed, carboplatin and exemestane.
IV. Analyze tumor tissue biomarkers for potential correlation with response.
OUTLINE: This is a dose-escalation study of exemestane.
Patients receive exemestane orally (PO) once daily (QD) on days 1-28 and pemetrexed disodium intravenously (IV) over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study of Carboplatin, Pemetrexed and Exemestane in Post-menopausal Women With Metastatic Non-squamous NSCLC|
|Actual Study Start Date :||September 7, 2012|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Treatment (exemestane, pemetrexed disodium, and carboplatin)
Patients receive exemestane PO QD on days 1-28 and pemetrexed disodium IV over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: pemetrexed disodium
Other Names:Drug: carboplatin
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studiesOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessment
- Tabulation, grading, and attribution of serious adverse events (SAEs) and adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 3 years ]
- Proportion achieving clinical response [ Time Frame: Up to 3 years ]For categorical markers Fisher's exact test will be used. The log rank test will be used to examine association between categorical markers and time to disease progression. For quantitative markers one-way ANOVA will be used. Cox-proportional hazards regression models will be used to correlate quantitative markers with time to disease progression. Pearson correlations will be used between pairs of quantitative markers. If there is significant non-normality the Kendall correlation coefficients will be used. Mixed effects models will be used to quantify markers at multiple time points.
- Quality of life in patients treated with pemetrexed disodium, carboplatin and exemestane [ Time Frame: Up to 3 years ]Quality of life measures will be compared between response categories (ANOVA) and the effect of time on therapy will be assessed with mixed effects models.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664754
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Edward Garon||Jonsson Comprehensive Cancer Center|