Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Carboplatin

Cetuximab

Everolimus

Antineoplastic Agents, Immunological

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Treatment arm with carboplatin, cetuximab and RAD001

Will be given as a 30 minutes intravenous (IV) infusion on days 1, 8, and 15 of each 28 day cycle. The starting dose of carboplatin will be area under the plasma-concentration time curve (AUC) = 2 mg/ml.min. Appropriate dose reductions will be done for toxicity for subsequent cycles.

Will be given on days 1, 8, 15 and 22 of each 29 day cycle. On week 1, a loading dose of 400 mg/m² will be given. From week 2 onwards, the dose of cetuximab will be 250 mg/m².

For phase I, dose escalation will be 2.5 mg, 5 mg, 7.5 mg or 10 mg given orally on a daily basis.

RAD001

Nabil F. Saba, MD

The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination.

The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.

A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer

A Phase I/IIB Study of Combination Weekly Carboplatin, Cetuximab and Dose Escalation of RAD001 in Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if only 1 patient experienced DLT, then 3 more patients were enrolled at the same dose level. If none of the 3 additional patients experienced DLT, the dose was escalated; otherwise, the dose level decreased. Dose reduction continued until a dose level was reached at which 6 patients had been treated and at most 1 DLT was observed.

Objective tumor responses were assessed every 2 cycles of chemotherapy with computed tomography or positron emission tomography/ computed tomography scans in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Novartis

Emory University

Physician

Carboplatin, cetuximab and RAD001 (everolimus)

Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis

Carboplatin, Cetuximab and Everolimus

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Limitations of this analysis include the small sample size in this phase 1b study, a patient population with mixed primary sites of disease, and variable doses of everolimus.

Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)

Everolimus Dose Level 1 DLT

Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)

Everolimus Dose Level -1 DLT

To Measure the Safety and Clinical Effectiveness of the Combination of Carboplatin, Cetuximab and RAD001 in Patients With Advanced (Recurrent or Metastatic) Head and Neck Cancer

Spots Global Cancer Trial Database for recurrent metastatic squamous cell carcinoma of the head and neck (scchn)