Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer (MARVEL)
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|ClinicalTrials.gov Identifier: NCT00738881|
Recruitment Status : Terminated (Slow accrual)
First Posted : August 21, 2008
Results First Posted : October 2, 2014
Last Update Posted : October 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer||Drug: Erlotinib Hydrochloride Drug: Pemetrexed Disodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MARVEL: Marker Validation of Erlotinib in Lung Cancer- A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2014|
Experimental: Arm I (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Erlotinib Hydrochloride
Experimental: Arm II (pemetrexed disodium)
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Pemetrexed Disodium
- Progression-free Survival (PFS) [ Time Frame: Time from randomization to the first date of documented disease progression or death, assessed up to 5 years ]Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.
- Time to Treatment Failure [ Time Frame: The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years ]The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.
- Overall Survival [ Time Frame: Time from randomization to time of death from any cause, assessed up to 5 years ]Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.
- Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher's exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.
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): NCT00738881
|Principal Investigator:||Alex Adjei||Alliance for Clinical Trials in Oncology|