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RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN

NCT01009346 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-07-17

Study results available
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Summary

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).

Secondary Objectives

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,

Conditions

Interventions

DRUG

RAD001

Dose Level -1 2.5mg/day Dose Level 1 5mg/day\* Dose Level 2 10mg/day MTD RAD001

DRUG

Cetuximab

250mg/m2/week

DRUG

Cisplatin

40mg/m2 Day 1, 8 every 28 days

DRUG

Carboplatin

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.

Sponsors & Collaborators

Principal Investigators

  • Shanthi Marur, MD · Johns Hopkins SKCCC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009346 on ClinicalTrials.gov