Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy

NCT01682031 | Terminated Phase 2 Results DMC

• 2 other identifiers: I 107807NCI-2009-01503
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis

Conditions

Chemotherapeutic Agent Toxicity; Mucositis; Radiation Toxicity; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Xerostomia

Outcome Measures

Primary Outcomes (1)

• Incidence of >= Grade 3 Mucositis

  Will be compared as difference in proportions with 95% confidence intervals.

  Up to 5 years

Secondary Outcomes (7)

• Tumor Complete Response Rate

  Up to 5 years post-treatment

• Relapse-free Survival (RFS)

  At 1 year

• Overall Survival

  Up to 5 years post-treatment

• Quality of Life

  Up to 1 year post-treatment

• Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia

  Up to 5 years post-treatment

Study Arms (2)

Arm I (placebo, cisplatin, and radiotherapy)

PLACEBO COMPARATOR

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

Other: placebo; Drug: cisplatin; Radiation: radiation therapy; Procedure: quality-of-life assessment

Arm II (selenomethionine, cisplatin, and radiotherapy)

EXPERIMENTAL

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

Dietary Supplement: selenomethionine; Drug: cisplatin; Radiation: radiation therapy; Procedure: quality-of-life assessment

Interventions

selenomethionine DIETARY_SUPPLEMENT

Given PO

Arm II (selenomethionine, cisplatin, and radiotherapy)

placebo OTHER

Given PO

Also known as: PLCB

Arm I (placebo, cisplatin, and radiotherapy)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Arm I (placebo, cisplatin, and radiotherapy); Arm II (selenomethionine, cisplatin, and radiotherapy)

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Arm I (placebo, cisplatin, and radiotherapy); Arm II (selenomethionine, cisplatin, and radiotherapy)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (placebo, cisplatin, and radiotherapy); Arm II (selenomethionine, cisplatin, and radiotherapy)

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses
• Stage III, IVa or IVb disease
• No prior definitive surgery for present diagnosis
• Appropriate candidate for concurrent cisplatin and radiation as definitive treatment; patients who receive induction chemotherapy as part of a definitive treatment program that will include concurrent CRT are eligible for this study
• Hemoglobin \>= 10 g/dL (100 g/l)
• Absolute neutrophil count \>= 2,000 cells/mm\^3 (2 x 10\^9/l)
• Platelets \>= 100,000 cells/mm\^3 (100 x 10\^9/l)
• Serum creatinine =\< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance \>= 50 ml/min using the Cockcroft-Gault formula
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Able to give written informed consent
• Be willing and able to comply with study procedures

You may not qualify if:

• Non-regional metastatic disease (stage IVc)
• Previous malignancy within the last 5 years except for adequately treated basal or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
• Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would compromise delivery of a radical dose to the HNSCC
• Known to be positive for hepatitis C or human immunodeficiency virus (HIV)
• Unable to tolerate oral medication (unless a feeding tube is in place)
• History of hypersensitivity to platinum drugs
• Symptomatic peripheral neuropathy \>= National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade II
• Pregnant, lactating or unwilling to use adequate contraception
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Planned use of amifostine for prophylaxis against radiation-induced xerostomia
• Patients taking selenium supplements in excess of 100 ug/day
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during the study

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

MeSH Terms

Conditions

Mucositis; Radiation Injuries; Squamous Cell Carcinoma of Head and Neck; Xerostomia

Interventions

Selenomethionine; Cisplatin; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Organoselenium Compounds; Organic Chemicals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Physical Phenomena

Limitations and Caveats

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: June 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1); NZ (1)