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

NCT00536952 | Unknown Early Phase 1 DMC

• 3 other identifiers: NU 06N2STU00001045GENENTECH-NU-06N2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Arm 1

EXPERIMENTAL

Pulmozyme

Drug: Pulmozyme; Radiation: Radiation Therapy

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Radiation: Radiation Therapy

Interventions

Pulmozyme DRUG

Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer

Also known as: dornase alfa inhalation solution

Arm 1

Placebo DRUG

Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer

Arm 2

Radiation Therapy RADIATION

5 days per week for 4 weeks

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

dornase alfa; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Bharat B. Mittal, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: February 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2016
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (1)