Paclitaxel, Cisplatin, and Cetuximab Followed By Cetuximab and Intensity-Modulated Radiation Therapy in Treating Patients With HPV-Associated Stage III or Stage IV Cancer of the Oropharynx That Can Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01084083
First received: March 9, 2010
Last updated: July 12, 2012
Last verified: October 2011
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well they work when followed by cetuximab and two different doses of intensity-modulated radiation therapy in treating patients with HPV-associated stage III or stage IV cancer of the oropharynx that can be removed by surgery.


Condition Intervention Phase
Head and Neck Cancer
Precancerous Condition
Biological: cetuximab
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Induction Chemotherapy Followed by Cetuximab (Erbitux) With Low Dose vs. Standard Dose IMRT in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 2-year progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Objective response [ Designated as safety issue: No ]
  • Quality of life as assessed at baseline and at 1, 6, 12, and 24 months after completion of study treatment [ Designated as safety issue: No ]
  • Correlative biomarker studies [ Designated as safety issue: No ]

Estimated Enrollment: 83
Study Start Date: March 2010
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 5 weeks (27 fractions). Patients also receive cetuximab IV over 1-2 hours once weekly for 6 weeks.
Biological: cetuximab
Given IV
Radiation: intensity-modulated radiation therapy
Patients undergo low-dose radiotherapy
Experimental: Group 2
Patients undergo standard-dose IMRT 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cetuximab IV over 1-2 hours once weekly for 7 weeks.
Biological: cetuximab
Given IV
Radiation: intensity-modulated radiation therapy
Patients undergo low-dose radiotherapy

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx as determined by H&E staining

    • Newly diagnosed disease
    • Resectable disease OR disease that is expected to become resectable after study treatment
    • Stage III, IVA, or IVB disease as determined by imaging studies (CT scan with IV contrast or MRI required) and a complete head and neck exam
  • Paraffin-embedded tumor specimen available for central confirmation of HPV-associated disease as determined by H&E staining and in-situ hybridization (ISH) for HPV-16 and IHC for p16

    • HPV-associated disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive
    • Non-HPV-associated disease is defined as p16 IHC-negative
  • NOTE: If there is limited tumor material, p16 IHC will be performed before HPV-16 ISH
  • Measurable disease of the primary tumor or nodes by clinical and radiographic methods, defined as a lesion that is ≥ 2 cm in at least one dimension by clinical exam AND by radiographic exam with CT scan or MRI (or a lesion that is ≥ 1 cm in at least one dimension if the radiographic exam utilizes spiral CT scan)
  • No primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine
  • No evidence of distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Granulocytes ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total serum bilirubin ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of another malignancy (except for carcinoma in situ of the cervix and/or nonmelanomatous skin cancer) unless it has been curatively treated and the patient has been disease-free for ≥ 2 years
  • Patients with any of the following within the past 6 months are eligible provided they have been evaluated by a cardiologist and/or neurologist before study entry:

    • NYHA class III-IV congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Unstable angina
    • Myocardial infarction (with or without ST elevation)
  • No uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within the past 30 days
  • No concurrent illness likely to interfere with study therapy or to prevent surgical resection
  • No prior severe infusion reaction to a monoclonal antibody

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior radiotherapy above the clavicles
  • No prior surgery with curative intent for this disease (complete head and neck exam with biopsy allowed)
  • No prior therapy specifically and directly targeting the EGFR pathway
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084083

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Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Shanthi Marur, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01084083     History of Changes
Other Study ID Numbers: CDR0000665170, ECOG-E1308
Study First Received: March 9, 2010
Last Updated: July 12, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
human papilloma virus infection
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
tongue cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Precancerous Conditions
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014