Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

NCT00409331 | Terminated Phase 2 Results

• 1 other identifier: 2006-0234
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives:

• When the mean dose is \< 24-26 Gy (shift recovery time to left)
• When the mean dose is \> 24-26 Gy (DVH shift)
• To observe mucositis in the following lower dose RT areas:
• Upper lip
• Lower lip
• Right cheek
• Left cheek
• Right ventral and lateral tongue
• Left ventral and lateral tongue
• Floor of the mouth
• Soft palate
• Hard palate.
• To observe the incidence and patterns of occipital scalp epilation;
• To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
• To further evaluate the safety profile of amifostine in this patient population.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; HNSCC; Submandibular and Sublingual Salivary Sparing; Amifostine; Ethyol; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 12-month Clinically Relevant Salivary Flow (CRSF)

  Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.

  12 months

Study Arms (1)

IMRT + Amifostine

EXPERIMENTAL

Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.

Drug: Amifostine; Procedure: Intensity- Modulated Radiation Therapy

Interventions

Amifostine DRUG

500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.

Also known as: Ethyol

IMRT + Amifostine

Intensity- Modulated Radiation Therapy PROCEDURE

2.0 to 2.2 Gy delivered in 30 fractions

Also known as: IMRT

IMRT + Amifostine

Eligibility Criteria

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

You may qualify if:

• Adult men and women of at least 18 years of age at the time of patient entry;
• Women of reproductive potential (defined as being \<1 year post-menopausal) must have a negative serum pregnancy test within 7 days of study entry;
• Men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the informed consent is signed, and must agree to continue using such precautions while receiving IMRT through 6 weeks after the last dose of amifostine or RT, whichever is the last therapy discontinued;
• Patients undergoing definitive or post-operative IMRT as follows:
• Definitive Patients: Histology confirmed unknown primary T0N1-2bM0 or oropharynx Stage I, II, III, IV (TX, T1-T2, favorable T3 (exophytic) N0-N2b, M0), small volume primary and nodal, not requiring chemotherapy during RT (i.e., induction chemo is acceptable as well as concurrent biological therapy e.g., Cetuximab), squamous cell carcinoma (AJCC Staging of HNSCC). Lymph nodes bilaterally of the neck are at risk for metastatic disease and require irradiation per clinical judgment.
• Post-operative Patients: Histology confirmed oral cavity, oropharynx, larynx and hypopharynx squamous cell carcinoma (AJCC Staging of HNSCC): \*Stage III and IV squamous cell carcinoma treated with surgery as the primary modality requiring post-operative RT, but not receiving concurrent chemotherapy. \*Indications for post-operative RT include: unfavorable T3 and T4 primaries, compromised margins, nodal metastases, extracapsular nodal extension, perineural invasion and lymphovascular invasion.
• Zubrod performance status of 0 or 1
• Adequate nutritional status as determined by the treating physician in conjunction with consultation with clinical nutritionists, as indicated.
• Hemoglobin must be greater than or equal to 10 g/dL.
• At least one parotid should keep a mean RT dose of \< 24-26 Gy. If this cannot be achieved on one side, then the contralateral parotid dosing goal is to keep the mean dose as low as possible, typically \<15 Gy.
• It is anticipated that at least one submandibular gland will receive a mean dose \>24-26 Gy.
• Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.

You may not qualify if:

• Evidence of significant wound infection, fistula, or major wound dehiscence at time of patient entry.
• Carcinomas of the paranasal sinuses, nasopharynx, or N3 at time of patient entry.
• Presence of prior malignancies \<5 years other than non-melanoma skin cancer or cervical, breast or bladder cancer in situ.
• T3N0 glottic cancer at time of patient entry.
• Prior chemotherapy for other cancer within less than or equal to 3 years prior to patient entry.
• Planned concurrent or adjuvant chemotherapy.
• Less than gross total resection for patients on post-operative RT.
• Prior head neck irradiation except for localized non-melanomatous cutaneous carcinomas.
• Salivary gland disease, e.g. Sjogren's disease at time of patient entry.
• Pregnant or nursing at the time of patient entry or positive serum pregnancy test within 7 days of study entry.
• Use of pilocarpine or cevimeline during participation in the study.
• General medical or psychological conditions that might preclude the patient from completion of the study or from understanding and signing the informed consent.
• Evidence of distant metastases.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• MedImmune LLC: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

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

Interventions

Amifostine; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Mark Chambers, DMD / Associate Professor
• Organization: UT MD Anderson Cancer Center

713-745-2672

Study Officials

• Mark Chambers, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: December 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: January 18, 2010

Record last verified: 2012-07

Locations

US (1)