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Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cetuximab
cisplatin
intensity-modulated radiation therapy
Nab-Paclitaxel
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent hypopharynx Cancer, recurrent larynx Cancer, recurrent verrucous carcinoma, squamous cell carcinoma, recurrent oral cavity cancer, recurrent metastatic occult primary cancer, recurrent oropharynx cacner, recurrent paranasal sinus and nasal cavity cancer, tongue cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract

  • Recurrent disease or second primary SCC

    • Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
    • Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
    • More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy

  • Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)

    • No signs of carotid exposure
  • No primary nasopharyngeal or salivary gland tumor
  • Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan
  • No distant metastasis

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • ANC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Bilirubin < 1.5 mg/dL
  • AST or ALT < 2 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded

  • No active cardiac disease, including any of the following:

    • Unstable angina
    • Uncontrolled hypertension
    • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
    • Uncontrolled arrhythmia
    • Congestive heart failure
    • At least 3 heart-related hospitalizations within the past year
  • No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • No concurrent medical illness that would impair patient tolerance to therapy or limit survival
  • No other invasive malignancy within the past 2 years
  • No pre-existing peripheral sensory neuropathy ≥ grade 2
  • No prior severe infusion reaction to a monoclonal antibody
  • No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery
  • Prior cisplatin and cetuximab allowed
  • At least 6 months since prior radiotherapy or chemotherapy
  • No prior radiotherapy > 75 Gy

  • No prior chemotherapy for recurrent head and neck cancer

    • Prior chemotherapy as a component of the primary treatment allowed

  • No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer

    • Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment

Sites / Locations

  • University Hospitals of Cleveland
  • Baylor Research Institute
  • University of Texas Southwestern Medical Center - Dallas
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm: Chemotherapy with Concurrent Radiation therapy

Arm Description

Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.

Secondary Outcome Measures

Number of Participants With Acute and Late Toxicities
Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.

Full Information

First Posted
January 30, 2009
Last Updated
August 19, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00833261
Brief Title
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
Official Title
A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2008 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Detailed Description
OBJECTIVES: Primary To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck. Secondary To determine the progression-free survival and local-regional progression in these patients. To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen. To determine the pattern of disease progression in these patients. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent hypopharynx Cancer, recurrent larynx Cancer, recurrent verrucous carcinoma, squamous cell carcinoma, recurrent oral cavity cancer, recurrent metastatic occult primary cancer, recurrent oropharynx cacner, recurrent paranasal sinus and nasal cavity cancer, tongue cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm: Chemotherapy with Concurrent Radiation therapy
Arm Type
Experimental
Arm Description
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
cetuximab
Other Intervention Name(s)
chemo
Intervention Description
cetuximab
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
chemo
Intervention Description
cisplatin
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
IMRT
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Other Intervention Name(s)
chemo
Intervention Description
Nab-Paclitaxel
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
Time Frame
2 year from the date of enrollment
Secondary Outcome Measure Information:
Title
Number of Participants With Acute and Late Toxicities
Description
Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.
Time Frame
6 months within the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract Recurrent disease or second primary SCC Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) No signs of carotid exposure No primary nasopharyngeal or salivary gland tumor Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan No distant metastasis PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% ANC ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) Bilirubin < 1.5 mg/dL AST or ALT < 2 times upper limit of normal Creatinine clearance ≥ 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded No active cardiac disease, including any of the following: Unstable angina Uncontrolled hypertension Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) Uncontrolled arrhythmia Congestive heart failure At least 3 heart-related hospitalizations within the past year No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year No concurrent medical illness that would impair patient tolerance to therapy or limit survival No other invasive malignancy within the past 2 years No pre-existing peripheral sensory neuropathy ≥ grade 2 No prior severe infusion reaction to a monoclonal antibody No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior surgery Prior cisplatin and cetuximab allowed At least 6 months since prior radiotherapy or chemotherapy No prior radiotherapy > 75 Gy No prior chemotherapy for recurrent head and neck cancer Prior chemotherapy as a component of the primary treatment allowed No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29346519
Citation
Awan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.
Results Reference
derived

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Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

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