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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: NATL COMP CA NETWORK; Pfizer
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Everolimus; Paclitaxel; Sirolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.