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Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

Primary Purpose

HEAD & NECK Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HEAD & NECK Cancer focused on measuring MAB C225(CETUXIMAB)(ANTI-EGFR), TAXOL (PACLITAXEL), Radiation Therapy, 08-084

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage III-IVB)
  • Karnofsky performance status ≥ or = to 70%
  • Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl, platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl
  • Adequate hepatic function:

Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used

  • Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
  • Women of childbearing potential must have a negative pregnancy test
  • Patients must have ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll
  • Prior radiation therapy for head and neck cancer
  • Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
  • Inability to comply with study and/or follow-up procedures
  • Women who are pregnant or lactating
  • Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina, auto-immune connective tissue disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • History of severe infusion reaction to a monoclonal antibody
  • Patients with nasopharyngeal carcinoma are not eligible

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memoral Sloan Kettering Cancer Center@Phelps

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Cetuximab loading dose, 400 mg/m2 intravenously (IV) IMRT, 1 fraction/day, up to total of approximately 70 Gy, over approximately 33 treatment days Cetuximab 250 mg/m2 weekly IV X 7 weeks Albumin-bound paclitaxel (Abraxane®) weekly IV X 7 weeks, according to dose escalation scheme

Outcomes

Primary Outcome Measures

To establish the phase II recommended dose of weekly intravenous albumin-bound paclitaxel (Abraxane®) given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC.

Secondary Outcome Measures

To establish the safety and tolerability of weekly albumin-bound paclitaxel + cetuximab + RT for patients with HNSCC.

Full Information

First Posted
August 15, 2008
Last Updated
August 9, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Celgene Corporation, National Comprehensive Cancer Network
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1. Study Identification

Unique Protocol Identification Number
NCT00736619
Brief Title
Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)
Official Title
Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Celgene Corporation, National Comprehensive Cancer Network

4. Oversight

5. Study Description

Brief Summary
For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein. Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HEAD & NECK Cancer
Keywords
MAB C225(CETUXIMAB)(ANTI-EGFR), TAXOL (PACLITAXEL), Radiation Therapy, 08-084

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cetuximab loading dose, 400 mg/m2 intravenously (IV) IMRT, 1 fraction/day, up to total of approximately 70 Gy, over approximately 33 treatment days Cetuximab 250 mg/m2 weekly IV X 7 weeks Albumin-bound paclitaxel (Abraxane®) weekly IV X 7 weeks, according to dose escalation scheme
Intervention Type
Other
Intervention Name(s)
Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)
Intervention Description
All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity-modulated radiation therapy) administered concurrently with cetuximab (400 mg/m2 intravenous loading dose one week prior to radiation therapy, followed by 250 mg/m2 weekly intravenous infusions). To explore different dose levels of nanoparticle albumin-bound paclitaxel (Abraxane®) given intravenously weekly with the standard regimen of weekly cetuximab + daily radiation therapy. The total number of planned cetuximab infusions is 8 (loading dose, plus 7 weekly infusions concurrent with radiation therapy). The total number of planned albumin-bound paclitaxel infusions is 7 (all concurrent with radiotherapy). Five dose levels of weekly intravenous (IV) albumin-bound paclitaxel will be explored.
Primary Outcome Measure Information:
Title
To establish the phase II recommended dose of weekly intravenous albumin-bound paclitaxel (Abraxane®) given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC.
Time Frame
conclusion of study
Secondary Outcome Measure Information:
Title
To establish the safety and tolerability of weekly albumin-bound paclitaxel + cetuximab + RT for patients with HNSCC.
Time Frame
conclusion of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage III-IVB) Karnofsky performance status ≥ or = to 70% Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl, platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl Adequate hepatic function: Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter Women of childbearing potential must have a negative pregnancy test Patients must have ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll Prior radiation therapy for head and neck cancer Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living) Inability to comply with study and/or follow-up procedures Women who are pregnant or lactating Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina, auto-immune connective tissue disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study History of severe infusion reaction to a monoclonal antibody Patients with nasopharyngeal carcinoma are not eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pfister, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Commack
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center@Phelps
City
Sleepy Hollow
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24496920
Citation
Fury MG, Sherman EJ, Rao SS, Wolden S, Smith-Marrone S, Mueller B, Ng KK, Dutta PR, Gelblum DY, Lee JL, Shen R, Kurz S, Katabi N, Haque S, Lee NY, Pfister DG. Phase I study of weekly nab-paclitaxel + weekly cetuximab + intensity-modulated radiation therapy (IMRT) in patients with stage III-IVB head and neck squamous cell carcinoma (HNSCC). Ann Oncol. 2014 Mar;25(3):689-694. doi: 10.1093/annonc/mdt579. Epub 2014 Feb 3.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

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