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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Squamous Cell Cancer; Head and Neck Cancer

Intervention: Temsirolimus + Weekly Paclitaxel + Carboplatin (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
David Pfister, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

Official title: A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatin.

To determine the objective response rate (CR or PR) after two cycles of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC

Secondary outcome:

To establish the safety of temsirolimus + weekly paclitaxel + carboplatin

To estimate median overall survival

To identify potential molecular markers of resistance to mTOR inhibition in tumor specimens obtained as part of routine clinical care

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey 07939, United States

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, 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 10591, United States

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: November 2009
Last updated: April 22, 2015

Page last updated: August 23, 2015

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