Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Papilloma

Carcinoma, Basal Cell

Breast Neoplasms, Male

Granuloma

Carcinoma, Adenoid Cystic

Laryngeal Diseases

Esthesioneuroblastoma, Olfactory

Carcinoma, Acinar Cell

Carcinoma, Verrucous

Papilloma, Inverted

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Small Cell Lung Cancer

Breast Cancer, Male

Laryngeal Cancer

Hypopharyngeal Cancer

Adenoid Cystic Carcinoma

Olfactory Neuroblastoma

Acinic Cell Carcinoma

Camurati-Engelmann Disease

Mucoepidermoid Carcinoma

Metastatic Squamous Neck Cancer With Occult Primary

Midline Lethal Granuloma

All Drugs and Chemicals

Herbal and Botanical

Mitogens

Cola

Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy

Venipuncture for blood samples. Samples will be tested for TGF-beta.

venipuncture

Radiation treatments vary according to type of cancer and by patient per doctors' recommendation

radiation therapy

A. Bapsi Chakravarthy, MD

RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.

PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

OBJECTIVES:

* To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.

OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury

TGF-beta is a protein that can be detected in the blood.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Associate Professor

Digestive System Diseases

Pain

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Acute Graft Versus Host Disease

Tongue Cancer

Central Nervous System Depressants

Psychotropic Drugs

Anti-Allergic Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Doxepin

Diphenhydramine

Promethazine

Hypnotics and Sedatives

Antidepressive Agents

Antidepressive Agents, Tricyclic

Histamine Antagonists

Histamine

Histamine phosphate

Neurotransmitter Agents

Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.

Patients receive placebo oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.

doxepin hydrochloride

placebo

Robert C. Miller, MD

RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.

PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (\< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)\* over 1 minute on day 1. Patients may crossover to arm II on day 2.
* Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)\* over 1 minute on day 1.

Patients may crossover to arm I on day 2. The primary and secondary objectives are detailed below.

Primary Objective:

Determine whether doxepin oral rinse is effective in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at 5,15, 30, 60, 120 and 240 minutes

Secondary Objectives:

1. Assess the adverse event profile of doxepin rinse using a patient-reported questionnaire at 5, 15, 30, 60, 120 and 240 minutes for domains of unpleasant taste, burning or stinging discomfort, and drowsiness.
2. Compare the incidence of using alternative analgesics before 4 hours, between the doxepin oral rinse and placebo arms.
3. Assess patient preference for continued therapy with oral rinse after initial test rinse or after the cross-over phase.

NOTE: \* Patients are instructed to avoid taking medications for mucositis pain 60 minutes before and after study medication.

After completing study therapy, patients have the option to receive doxepin hydrochloride oral rinse every 4 hours as needed during radiotherapy.

Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes after study medication. Patients who choose to continue doxepin hydrochloride oral rinse also complete weekly questionnaires.

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.

The total taste of the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6 , and analyzed in the same way as the primary endpoint. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes the TASTE OF THE ORAL RINSE now?') used 11-point numerical analog scales (0 (acceptable taste) to 10(terrible taste), with higher values representing worse outcome) to evaluate the total taste of the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.

The total stinging or burning from the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes any STINGING OR BURNING FROM THE ORAL RINSE now?') used 11-point numerical analog scales (0 (no stinging or burning) to 10 (worst stinging or burning possible) scores) to total stinging or burning from the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.The statistical analysis will be the same as the primary analysis.

The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.

The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .

After each dose was administered, patients were asked if they would like to continue rinses with that particular agent. The percentage of patients who expressed an interest in continuing therapy are reported below.

Alliance for Clinical Trials in Oncology

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported.

Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.

Arm I (Doxepin-Placebo)

Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.

Arm II (Placebo-Doxepin)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Robert C. Miller, M.D.

If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis. The primary analysis of the total pain reduction will only use primary data from the first phase.

Total Pain Reduction (Mouth and Throat)

If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.

Total Taste of the Oral Rinse

Total Stinging or Burning From the Oral Rinse

Total Drowsiness Increase

At 2 hours after the initial mouthwash

At 4 hours after the initial mouthwash

Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash

Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride

Overall Study

Salivary Gland Neoplasms

Mouth Neoplasms

Salivary Gland Diseases

Oral Cancer

Antineoplastic Agents

Gemcitabine

Antimetabolites

The first group, referred to as intercalated duct will include Aadenoid cystic carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, and adenocarcinoma.

- Gemcitabine iv 30 min infusion on days 1,8, and 15 of each 28 day cycle.

-- Participants will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

The second group, referred to as excretory duct, will include: squamous cell carcinoma and mucoepidermoid carcinoma.

* Gemcitabine iv 30 min infusion on days 1,8, and 15 of each 28 day cycle.
* Participants will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

gemcitabine

Marshall R. Posner, MD

The purpose of this study is to see how patients with incurable salivary gland cancer, who have not had chemotherapy before, respond to Gemcitabine. The investigators are trying to find out what effects (good and bad) Gemcitabine has on participants and salivary gland cancer.

Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer, including; bladder cancer, breast cancer, certain types of lung cancer, ovarian cancer, and pancreas cancer. Gemcitabine has yet to be studied for efficacy in subjects with salivary gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in this population.

OBJECTIVES:

* Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine.
* Evaluate the time to progression and toxicity of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV for 30 minutes on days 1, 8, and 15 of each 28 day course. Patients receive a minimum of 2 courses of treatment. Patients may continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

.

Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery

Gemcitabine for Advanced Salivary Cancer: A Phase II Study

Dana-Farber Cancer Institute

Haddad, Robert MD

Behaviors and Mental Disorders

Quality of Life

questionnaire administration

survey administration

quality-of-life assessment

Barbara Murphy, MD

RATIONALE: Developing a questionnaire that can be used to assess the quality of life among people who have a family member with cancer may help the study of cancer in the future.

PURPOSE: This clinical trial is studying quality of life among families with a member who is a cancer patient.

OBJECTIVES:

* Develop and conduct preliminary validation of a Family Quality of Life Questionnaire for use with families with an adult cancer patient, with the measure appropriate for use for both research and clinical assessment purposes.
* Generate an initial item pool for the measure (step 1).
* Reduce the item pool based on a content validity assessment (step 2).
* Assess the psychometric properties and dimensionality of the measure (step 3).

OUTLINE:

* Step 1 (item generation): Items are generated through a literature review and a semi-structured interview with patients and their families. The purposes of the interview are to determine whether the five domains identified in the literature review (family interaction, family roles, family communication, family emotional support, overall family quality of life \[FQOL\]) are central areas of FQOL, and to determine if there are other important FQOL domains affected by cancer and its treatment. Patients and their family members are interviewed individually over 45-60 minutes. The initial item pool is generated based on the literature review and interviews.
* Step 2 (item review and reduction): The initial item pool is examined and reduced based on its content validity. Ten health care providers with a minimum of five years experience working with cancer patients rate the content validity of the proposed questionnaire. Experts receive a packet of questionnaires, including the objective of the study, the proposed questionnaire as developed in step 1, and the proposed questionnaire with its format modified for the examination of content validity. The content validity version uses a 4-point Likert format to assess each item's relevance, sufficiency (i.e., the extent to which it fully covers its intended domain) and clarity in relation to the construct (FQOL domain) that it is supposed to assess. Experts are asked to rate the overall format of the questionnaire in regards to ease of use and appropriateness, and for open-ended comments or suggestions. Items are modified or dropped based on the experts' review.
* Step 3 (final item selection and psychometric evaluation): Patients and family members complete the FQOL questionnaire developed in previous steps and other questionnaires with proven reliability and validity at baseline. Other questionnaires include the SF-36 (general QOL survey that is used widely in general population samples and patients, including cancer patients), the FACT-G for patients (instrument used to assess health-related QOL in cancer patients), with the version of the FACT-G modified by Northouse for the family member, the Family Interaction and Emotional Well-Being subscales (to examine family interaction and family emotional support of cancer families) of the Beach Center Family Quality of Life Scale (FQOL measure for families with a disabled child), the Balanced Cohesion subscale (to examine family interaction of cancer families) of the FACES IV (that assesses balanced and unbalanced family cohesion and family flexibility in general population), and the Family Communication Scale (a general survey used to assess family communication in the general population). Patients and family members complete the FQOL again 2 weeks after the initial assessment.

PROJECTED ACCRUAL: Approximately 210 cancer patients and 210 family members will be accrued for this study.

Family Quality of Life Among Families With a Member Who is a Cancer Patient

Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Squamous Cell Carcinoma of Head and Neck

Vasoconstrictor Agents

Respiratory System Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Epinephrine

Cisplatin

Racepinephrine

Epinephryl borate

Tubulin Modulators

Antimitotic Agents

carboplatin

cisplatin-e therapeutic implant

paclitaxel

Laurence Elias, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin-epinephrine injectable gel plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer.

OBJECTIVES: I. Determine the antitumor activity of intratumoral cisplatin-epinephrine injectable gel and systemic paclitaxel and carboplatin in patients with recurrent squamous cell carcinoma of the head and neck. II. Determine the safety of this regimen in this patient population. III. Determine the time to progression, pattern of progression, and rate of relapse of patients treated with this regimen. VI. Determine the time to response and duration of response of patients treated with this regimen. V. Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cisplatin-epinephrine gel intratumorally on days -15, -8, 1, 8, 15, and 22 for course 1 and days 1, 8, 15, and 22 for all subsequent courses. Patients also receive paclitaxel IV over at least 3 hours followed by carboplatin IV over at least 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve local complete response (CR) and no metastatic disease progression continue treatment with carboplatin and paclitaxel only. Patients who achieve total CR may receive 2 additional courses of carboplatin and paclitaxel. Patients are followed at 1-4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer

A Phase II Activity And Safety Study Of IntraDose (Cisplatin/Epinephrine Injectable Gel) When Given In Combination With Systematic Chemotherapy Paclitaxel And Carboplatin In The Treatment Of Patients With Squamous Cell Carcinoma Of The Head And Neck At First Relapse

Matrix Pharmaceutical

Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.

Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.

Given in 2 fractionated doses or 5 fractionated doses

stereotactic radiosurgery

Minh T. Truong, MD

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.

OBJECTIVES:

* To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as boost therapy after standard chemoradiotherapy in patients with locally advanced head and neck cancer.
* To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as salvage therapy in patients with locally recurrent head and neck cancer.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after prior standard therapy. Patients with residual disease after standard therapy are assigned to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to group 2.

All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning CyberKnife® stereotactic radiosurgery (SRS) treatment.

* Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
* Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly.

After completion of study treatment, patients are followed periodically for up to 2 years.

Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer

Median time to local failure based on regional or distant metastatic disease

Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment

United States Department of Defense

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer	NCT00897793	Breast Cancer Colorectal Canc... Head and Neck C... Lung Cancer Prostate Cancer	venipuncture radiation thera...	18 Years -	Vanderbilt-Ingram Cancer Center
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy	NCT01156142	Head and Neck C... Mucositis Oral Complicati... Pain	doxepin hydroch... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery	NCT00003744	Head and Neck C...	gemcitabine	18 Years -	Dana-Farber Cancer Institute
Family Quality of Life Among Families With a Member Who is a Cancer Patient	NCT00544336	Breast Cancer Colorectal Canc... Head and Neck C... Lung Cancer Prostate Cancer Solid Tumor	questionnaire a... survey administ... quality-of-life...	21 Years -	Vanderbilt-Ingram Cancer Center
Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer	NCT00022217	Head and Neck C...	carboplatin cisplatin-e the... paclitaxel	18 Years -	National Cancer Institute (NCI)
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery	NCT00003744	Head and Neck C...	gemcitabine	18 Years -	Dana-Farber Cancer Institute
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer	NCT00851253	Head and Neck C...	stereotactic ra...	18 Years -	Boston Medical Center
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy	NCT01156142	Head and Neck C... Mucositis Oral Complicati... Pain	doxepin hydroch... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor	NCT00079079	Head and Neck C...	carboplatin cisplatin gemcitabine hyd...	18 Years - 120 Years	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for salivary gland anaplastic carcinoma