Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01716195
First received: October 25, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether human papillomavirus (HPV)-positive head and neck cancer can be treated with a less aggressive regimen of radiation therapy and chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy (carboplatin/paclitaxel).


Condition Intervention Phase
Head and Neck Cancer
Other: 6 weeks of Radiotherapy
Other: 5 weeks of Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Defined as the time from registration to death.

  • Toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Assessed by NCI Common Toxicity Criteria for Adverse Effects, Version 4.0

  • Quality of Life Assessment [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N) and University of Washington Quality of Life (questionnaire)(UWQol)


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 weeks of Radiotherapy
Paclitaxel + Carboplatin (2 cycles) IV followed by Radiation Therapy (6 weeks) + Paclitaxel IV
Other: 6 weeks of Radiotherapy
If tumor does not significantly shrink after initial chemotherapy
Other Names:
  • Taxol
  • Paraplatin
Experimental: 5 weeks of Radiotherapy
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 (2 cycles) IV followed by Radiation Therapy (5 weeks) + Paclitaxel 175 mg/m2 IV
Other: 5 weeks of Radiotherapy
If tumor shrinks after initial chemotherapy
Other Names:
  • Taxol
  • Paraplatin

Detailed Description:

Given the toxicity of high dose cisplatin, attention has focused on identifying patients at lower risk for failure who may potentially benefit from less aggressive chemoradiotherapy approaches. HPV-positive Head and Neck Cancer responds favorably to radiation therapy. This has prompted investigators to suggest that patients with these cancers might be "over-treated" and unnecessarily subjected to the toxicity of intensive chemoradiotherapy with excessively high radiation doses.

This study will select patients with HPV-positive Head and Neck cancer for attenuated therapy and may have important implications for individualization of care in the future. The regimen of carboplatin and paclitaxel was selected for the induction chemotherapy phase because of its ease of administration, improved toxicity profile, high rates of dose delivery, and excellent published results showing high response rates and overall survival. This study will use induction chemotherapy primarily as a means to select HPV-positive Head and Neck Cancer patients, who may benefit from significant radiation dose de-intensification in the concurrent chemoradiotherapy phase of treatment. The rationale for this risk-adapted approach to local therapy based on HPV status is to administer effective comprehensive treatment individualized at diagnosis and after assessment of response to induction chemotherapy (for patients with HPV-positive tumors), thus avoiding unnecessary and potentially toxic treatment, and hence optimizing the therapeutic ratio.

  Eligibility

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

Inclusion Criteria:

  • Pathologically proven diagnosis of HPV-positive squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry.
  • Clinical stage III or IV disease; Note: Patients with M1 tumors are not eligible.
  • Appropriate stage for protocol entry, including no distant metastases, based upon minimum diagnostic workup
  • Zubrod Performance Status 0-1
  • Age > 18
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function
  • Pregnancy test within 4 weeks prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment)
  • Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
  • Patients with simultaneous primaries or bilateral tumors are excluded.
  • Patients who present with a cervical lymph node metastasis of unknown primary origin;
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
  • Prior radiotherapy that would result in overlap of radiation therapy fields;
  • Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses, or salivary glands;
  • Recurrent head and neck cancer;
  • Severe, active co-morbidity
  • Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Prior allergic reaction to the study drug(s) involved in this protocol.
  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: NCT01716195

Contacts
Contact: Corinne Turrell 916-734-3089

Locations
United States, California
University of California Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Heather Melanson    916-734-8628      
Principal Investigator: Megan Daly, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Megan Daly, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01716195     History of Changes
Other Study ID Numbers: CCRO022
Study First Received: October 25, 2012
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Human Papillomavirus
HPV

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014