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

Sponsor

Northwestern University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00536952

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arms

106

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Pulmozyme Drug: Placebo Radiation: Radiation Therapy	Early Phase 1

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Feb 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory) [5 times per week during study treatment and once per month up to 3 months post-treatment]
Quality of life as assessed weekly by the Functional Assessment of Cancer Therapy - Head & Neck Neck questionnaire [Weekly during study treatment and once per month up to 3 months post-treatment.]
Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire [Daily during radiation treatment]

Secondary Outcome Measures

Reduction in amount of thick oropharyngeal secretions associated with cancer therapy. [At baseline, prior to radiation and study treatment, and after radiation.]
Incidence of mucositis, infections, and aspiration pneumonia [Weekly during study treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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