RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN
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|ClinicalTrials.gov Identifier: NCT01009346|
Recruitment Status : Terminated (Toxicity)
First Posted : November 6, 2009
Results First Posted : June 9, 2014
Last Update Posted : July 17, 2018
1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN).
1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: RAD001 Drug: Cetuximab Drug: Cisplatin Drug: Carboplatin||Phase 1 Phase 2|
This was a dose escalation study with RAD001 in combination with cetuximab and cisplatin in recurrent/metastatic SCCHN. Patients with ECOG performance status 0-2, with no prior systemic therapy for recurrent/metastatic SCCHN were enrolled. The dose levels for RAD001 were 2.5mg, 5mg or 10 mg administered oral daily, cetuximab 250mg/m2 weekly infusion, and cisplatin 40mg/m2 days 1 and 8. Each cycle was 28 days. Safety monitoring plan was outlined in the protocol and study calendar at specific time points. Response was evaluated with CT/MRI and PET scans every 2 cycles. DLT criteria and MTD was defined.
Dose escalation followed the conventional 3+3 design.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of RAD001 in Combination w/ Cetuximab and Cisplatin as First-line Therapy in Recurrent & Metastatic Squamous Cell Cancer of the Head & Neck|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Daily RAD001 in combination with weekly cetuximab and cisplatin/ carboplatin on Day 1, 8 of each 28 day cycle.
Dose Level -1 2.5mg/day
Dose Level 1 5mg/day*
Dose Level 2 10mg/day
Other Name: Everolimus
Other Name: Erbitux
40mg/m2 Day 1, 8 every 28 days
Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:
Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance.
Other Name: cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)
- Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin. [ Time Frame: 6 months ]MTD will be defined as a) the dose of RAD001 producing DLT in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 10mg po qd with less than 33% rate of DLT
- Progression Free Survival (PFS) of RAD001 in Combination With Weekly Cetuximab and Cisplatin. [ Time Frame: 2 years ]Median number of months for which participants are free of progression after initiating treatment with RAD001 in combination with weekly cetuximab and cisplatin.
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): NCT01009346
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Shanthi Marur, MD||Johns Hopkins SKCCC|