Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Completed · Phase 1/Phase 2

Conditions studied: Squamous Cell Cancer, Head and Neck Cancer

In brief

The purpose of this study is to find out the good and bad effects that occur when temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.

Key facts

Study ID

NCT01016769

Run by

Memorial Sloan Kettering Cancer Center

People needed

48

Starts

2009-11-01

Expected to finish

2018-06-01

Last updated by the study team

2019-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have microscopically confirmed head and neck squamous cell carcinoma (HNSCC), recurrent and/or metastatic.
• Confirmation of HNSCC may be obtained from the primary site or metastatic disease.
• Patients must be at least 18 years of age.
• Karnofsky Performance status must be ≥ 70%.
• Disease must be measurable by RECIST criteria.
• At least 6 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
• Adequate organ function, as follows:
• Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 100 X 109/L, and hemoglobin ≥ 9 g/dL.
• Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal)
• Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 45 mL/min based on the standard Cockroft and Gault formula.
• Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
• Patients must sign an informed consent document.

You may not qualify if…

• Previous exposure to temsirolimus or other mTOR inhibitors
• More than 2 prior cytotoxic regimens in the recurrent/metastatic disease setting
• History of any brain metastases
• Patients who require concomitant medications that are metabolized by hepatic CYP3A4, due to potential drug-drug interaction with temsirolimus
• Patients with known active interstitial pneumonitis
• Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
• Women who are pregnant or lactating
• Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
• Diagnosis of Nasopharyngeal cancer is excluded.
• Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
• Therapeutic anticoagulation with Coumadin (warfarin)
• Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0).
• Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.

Where it is running

• Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
• Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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