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

NCT01016769

Last updated date
Study Location
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07939, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Cancer, Head and Neck Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pfizer Clinical Trials Contact Center

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Squamous Cell Cancer, Head and Neck CancerTemsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
NCT01016769
  1. Basking Ridge, New Jersey
  2. Commack, New York
  3. New York, New York
  4. Rockville Centre, New York
  5. Sleepy Hollow, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Official Title  ICMJE A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Cancer
  • Head and Neck Cancer
Intervention  ICMJE 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.

Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2009)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01016769
Other Study ID Numbers  ICMJE 09-131
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • NATL COMP CA NETWORK
  • Pfizer
Investigators  ICMJE
Principal Investigator:David Pfister, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2018

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