Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Head-Neck

Protocol H3E-MC-JMHR: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

Unique Data Set IDHeadNe_EliLill_2006_150
DownloadableYes
SponsorEli Lilly & CompanyData ProviderEli LillyTotal Study Enrolled Patients795Comparator (Control) Arm Enrolled Patients397RandomizationYesClinicalTrial.gov IDNCT00415194ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00415194
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

Protocol H3E-MC-JMHR: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

Trial Summary and Conditions

Study H3E-MC-JMHR (JMHR) is a double-blind, randomized, Phase 3 study in patients with HNC that is recurrent and not amenable to local therapy (surgery or radiation) or newly diagnosed distant metastatic disease. Approximately 790 patients are enrolled in this study. Eligible patients are randomized to one of the following treatment arms: Arm A (experimental arm): pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 on Day 1 every 21 days, Arm B (control arm): placebo plus cisplatin 75 mg/m2 on Day 1 every 21 days. Patients are evenly assigned (1:1 randomization) to the treatment arms based on the following randomization factors: Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2), previously treated for HNC (no versus yes), distant metastasis (no versus yes), prior platinum-based therapy (no versus yes), and country. The primary efficacy measure is OS. Secondary endpoints include PFS, ORR, and DoR; time to worsening (TTW) in dimensions of health-related quality of life (HRQoL) using FACT-H&N, change from baseline in dimensions of HRQoL using FACT-H&N, and safety.

Data Summary

Control arm data files for safety, efficacy, demographics, treatment exposure, concomitant medications, etc.

Study Objectives

The objectives of the study are to compare the following between Arms. The primary efficacy measure is OS. Secondary endpoints include PFS, ORR, and DoR; time to worsening (TTW) in dimensions of health-related quality of life (HRQoL) using FACT-H&N, change from baseline in dimensions of HRQoL using FACT-H&N, and safety.

Outcome Measures

The primary efficacy measure is OS. Secondary endpoints include PFS, ORR, and DoR; time to worsening (TTW) in dimensions of health-related quality of life (HRQoL) using FACT-H&N, change from baseline in dimensions of HRQoL using FACT-H&N, and safety.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: JMHR protocol amendment b_redacted.pdf

CRF: JMHR_acrf_redacted.pdf

DATA DICTIONARY: JMHR_define.pdf

DATA (COMPARATOR ARM): jmhr_control.zip