Nicotine Levels With Response Rates to Radiation Alone or With Chemo In Head & Neck Cancer

NCT01084733 | Completed DMC

• 2 other identifiers: MCC-06-0781-P3KNICOTINE-HN
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the relationship between serum nicotine levels and tumor response of squamous cell cancers of the head and neck (SCCHN) to radiotherapy alone or in combination with chemotherapy. Correlation of RECIST response, volumatic response, pathologic response (in patients receiving post-treatment neck dissection), and hemodynamic response (tumor oxygenation and blood flow) will be performed.

Conditions

Larynx Cancer; Lip Cancer; Oral Cavity Cancer; Pharyngeal Cancer; Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of serum cotinine with volumetric response

  RECIST criteria will be used as a correlate for standardization of tumor response. Volumetric analysis may provide better assessment of bulky tumor size that may have a large necrotic or hypoxic component that may be resistant to treatment. Furthermore, volumetric analysis has been associated with a higher rate of concordance to response based upon RECIST criteria.

  2 years from start of treatment

Secondary Outcomes (5)

• Correlation of serum cotinine with toxicities during treatment.

  90 days from start of treatment

• Correlation of serum cotinine with time to progression.

  2 years

• Correlation of serum cotinine with survival

  5 years from start of treatment

• Correlation of serum cotinine with response to treatment

  5 years

• Investigate the hemodynamic responses to different nicotine levels and different therapies (radiation alone, radiation + chemotherapy).

  End of Treatment

Eligibility Criteria

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

Study Population

Male or female aged 18 or older

You may qualify if:

• A: Male or female aged 18 or older
• B: Pathologically confirmed squamous cell carcinoma
• C: Measurable disease using CT, MRI, or panendoscopy
• D: Tumor sites to include:
• Oropharynx Hypopharynx Oral cavity Larynx Measurable disease with no evidence of primary
• E: Patients to be treated with radiotherapy or chemoradiotherapy as a primary treatment modality. Patients to be treated with radiotherapy in combination with platinum based chemotherapy will be considered for enrollment.
• F: Nutritional status to include patients that do not require placement of a feeding tube as well as patients that are feeding tube dependent. However, patients requiring total parenteral nutrition prior to initiation of treatment will be excluded.
• G: ECOG performance status of 0, 1 or 2.
• i: No evidence of active angina pectoris or ventricular arrhythmia's; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.) ii: Absolute neutrophil count of \> 1000/uL and platelet count \> 100,000/uL iii: Serum total bilirubin \< 1.5 mg/dL iv: Creatinine Clearance greater than 60 ml/min creatinine clearance to be calculated using the formula: (140 - age) x (wgt in kg) \* (serum creatinine) x (72)
• \* multiply by 0.85 for females v: If a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to treatment. Patients with grade II or greater neuropathy will be excluded from study.
• I: Standard of care treatment will require counseling against the use of tobacco products and can include nicotine replacement at the request of the patient and discretion of treating physician. Patients who continue to use tobacco products as well as patients using any form of cessation strategy (nicotine replacement, bupropion, or other) will be eligible for enrollment.
• J: Patients enrolled on experimental studies will be considered for enrollment with final selection to be made by Dr. Kudrimoti, Dr. Warren, Dr. Arnold, and Dr. Valentino.
• K: Ability to give informed consent

You may not qualify if:

• A: Pregnant females. Males and females of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
• B: Histology other than squamous cell carcinoma
• C: Patients without measurable disease using CT, MRI, or panendoscopy
• D: Patients eligible for surgical resection alone or with significant (\> 25%) surgical tumor debulking prior to radiotherapy will not be considered for enrollment. Furthermore, patients who are otherwise not candidates for radiotherapy at the discretion of the treating physician will be excluded from enrollment.
• E: Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
• F: Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.
• G: Prior chemotherapy, prior irradiation or surgery for SCCHN will not be allowed.
• H: Patients with metastatic disease will not be eligible for this study.
• I: Patients with grade II or greater peripheral neuropathy will be excluded from study.
• J: Patients receiving medication to prevent mucositis (palifermin, amifostine, or other).
• K: Patients requiring total parenteral nutritional support prior to the initiation of treatment will not be eligible for study.

Sponsors & Collaborators

• Mahesh Kudrimoti: lead

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be obtained weekly during the treatment phase. Serum will be collected and aliquoted into eppendorf tubes. Serum samples will be stored in -20C freezer until assayed for cotinine levels using Immulite immunoassay for cotinine (Immulite 2000 Assay, DPC, United States, Technical Services 800-372-1782).

MeSH Terms

Conditions

Laryngeal Neoplasms; Lip Neoplasms; Mouth Neoplasms; Pharyngeal Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases

Study Officials

• Mahesh Kudrimoti, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Faculty, Radiation Medicine

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: August 1, 2007
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)