Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00536952
First received: September 27, 2007
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

RATIONALE: Nebulized dornase alfa inhalation solution may decrease the thickness of saliva in the mouth and improve quality of life in patients undergoing radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether dornase alfa inhalation solution is more effective than a placebo in lessening the discomfort of treatment in these patients.

PURPOSE: This randomized clinical trial is studying how well dornase alfa inhalation solution works compared with a placebo in treating patients with stage III or stage IV head and neck cancer undergoing radiation therapy and chemotherapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: Pulmozyme
Drug: Placebo
Radiation: Radiation Therapy
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation and Chemotherapy

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory) [ Time Frame: 5 times per week during study treatment and once per month up to 3 months post-treatment ] [ Designated as safety issue: No ]
  • Quality of life as assessed weekly by the Functional Assessment of Cancer Therapy - Head & Neck Neck questionnaire [ Time Frame: Weekly during study treatment and once per month up to 3 months post-treatment. ] [ Designated as safety issue: No ]
  • Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire [ Time Frame: Daily during radiation treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in amount of thick oropharyngeal secretions associated with cancer therapy. [ Time Frame: At baseline, prior to radiation and study treatment, and after radiation. ] [ Designated as safety issue: No ]
  • Incidence of mucositis, infections, and aspiration pneumonia [ Time Frame: Weekly during study treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: February 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Pulmozyme
Drug: Pulmozyme
Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
Other Name: dornase alfa inhalation solution
Radiation: Radiation Therapy
5 days per week for 4 weeks
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
Radiation: Radiation Therapy
5 days per week for 4 weeks

Detailed Description:

OBJECTIVES:

  • To determine if use of nebulized dornase alfa inhalation solution can improve the overall daily symptom and quality of life as well as reduce treatment discomfort during radiotherapy and chemotherapy in patients with stage III or IV squamous cell carcinoma of the head and neck.
  • To determine if once daily nebulized dornase alfa inhalation solution given prior to radiotherapy can reduce thick oropharyngeal secretions associated with curative radiotherapy and chemotherapy in these patients.
  • To determine if reduction in thick oropharyngeal secretions with the use of nebulized dornase alfa inhalation solution can decrease the incidence of mucositis, infections, and aspiration pneumonia.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive nebulized dornase alfa inhalation solution via oral inhalation approximately 30 minutes prior to radiation therapy on days 1-5. Treatment continues for up to 4 weeks (weeks 3-6 of radiation therapy) in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive nebulized placebo via oral inhalation approximately 30 minutes prior to radiation therapy on days 1-5. Treatment continues for up to 4 weeks as in arm I.

All patients are assessed for treatment-related symptoms and treatment disturbance daily during radiation therapy. Patients are assessed for quality of life weekly during radiation therapy and then monthly during follow-up for 3 months. Clinical symptoms (i.e., mucositis, bacterial and fungal infections, and aspiration pneumonia) are also assessed weekly during radiation therapy.

Sputum samples are collected prior to initiating radiation therapy (at baseline) and periodically during week 3 of radiation treatment and evaluated for salivary DNA levels.

After completion of study therapy, patients are followed monthly for 3 months and then every 3-4 months for a minimum of 2 years.

  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 oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx

    • Stage III or IV disease
    • Confirmation from primary site and/or lymph nodes
  • Patients with a history of head and neck cancer allowed provided they have not received prior radiotherapy

    • Prior localized radiotherapy for skin cancer arising in the head and neck region is allowed
  • Planning to receive radiation therapy and chemotherapy to the head and neck regions with a minimum expected radiation dose of 60 Gy over 6 weeks

    • Chemotherapy may include but is not limited to, cisplatin or carboplatin, fluorouracil, hydroxyurea, docetaxel, and/or cetuximab

      • Induction chemotherapy allowed

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 50-100%
  • No prior allergic reaction or known sensitivity to dornase alfa inhalation solution
  • No significant active infection or other severe complicating medical illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent amifostine
  • No mouth wash 1 hour before or after dornase alfa inhalation solution administration
  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: NCT00536952

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Genentech
Investigators
Study Chair: Bharat B. Mittal, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00536952     History of Changes
Other Study ID Numbers: NU 06N2, STU00001045, GENENTECH-NU-06N2
Study First Received: September 27, 2007
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014