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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NATL COMP CA NETWORK
Pfizer
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01016769
First received: November 18, 2009
Last updated: February 10, 2014
Last verified: February 2014

November 18, 2009
February 10, 2014
November 2009
November 2014   (final data collection date for primary outcome measure)
  • To establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016769 on ClinicalTrials.gov Archive Site
  • To establish the safety of temsirolimus + weekly paclitaxel + carboplatin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To estimate median overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To identify potential molecular markers of resistance to mTOR inhibition in tumor specimens obtained as part of routine clinical care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Cancer
  • Head and Neck Cancer
Drug: Temsirolimus + Weekly Paclitaxel + Carboplatin

Temsirolimus Per dose escalation scheme Level 1 (15 mg) 2 (20 mg) Level 3 (25 mg) IVPB 30 minutes weekly (3 weeks on, 1 week off) days 1 and 8.

Paclitaxel 80 mg/m2 IVPB 1 hour weekly (2 weeks on, 1 week off) days 1 and 8. Carboplatin AUC 1.5 IVPB 30 minutes days 1 and 8. On Day 15 of each cycle, patients begin the rest week.

Experimental: Temsirolimus + Weekly Paclitaxel + Carboplatin

In Part 1 (Phase I) of the study, the primary endpoint is to establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatinPart 1 (Phase I) features a standard 3 + 3 phase I dose escalation design. Up to 3 dose levels are planned in the Phase I portion of the study.

In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed.

Intervention: Drug: Temsirolimus + Weekly Paclitaxel + Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016769
09-131
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • NATL COMP CA NETWORK
  • Pfizer
Principal Investigator: Matthew Fury, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP