Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Infections

Rare Diseases

Carcinoma

Nasopharyngeal Neoplasms

Recurrence

Head and Neck Neoplasms

Epstein-Barr Virus Infections

Virus Diseases

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Cc-486

Antimetabolites

Enzyme Inhibitors

CC-486 will be administered orally every day on Days 1-14 of a 21 day cycle at a dose of 300 mg. The first 6 participants of Asian-Pacific ethnicity will receive a starting dose of 200 mg. If there are no safety concerns, the 300 mg dose will be administered to all subsequent participants of Asian-Pacific ethnicity.

CC-486

Abderahim (Rahim) Fandi, MD, PhD

The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (\>4 responses \[complete response; partial response {CR/PR}\] out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.

Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

A Phase 2, Multicenter, International, Single Arm Study To Assess The Safety And Efficacy Of Single Agent Cc-486 (Oral Azacitidine) In Previously Treated Subjects With Locally Advanced Or Metastatic Nasopharyngeal Carcinoma

Overall response rate was defined as the combined incidence of Complete Response (CR) or Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met, based on independent radiology assessment according to RECIST 1.1 criteria.

Complete response was defined as the disappearance of all target lesions and non-target lesions; Partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline.

PFS was defined as the time from the date of start of the study treatment to the date of disease progression or death (any cause) on or prior to the data cut-off date for the statistical analysis, whichever occurred earlier, based on an independent radiology assessment of response using RECIST v1.1 criteria. Progressive disease was defined as at least a 20% increase in the sum of diameters of target or non-target lesions from nadir or appearance of a new lesion.

Overall survival was the time from the first dose of study drug to patient death from any cause. Participants who did not die were censored at the last known time the patient was alive date or the clinical data cutoff date, whichever was earlier.

Disease Control Rate (DCR) was defined as the percentage of participants with a CR, PR, confirmed ≥ 4 weeks after the criteria for response were first met, or stable disease for ≥ 16 weeks from the first treatment, based on independent radiology assessment using RECIST 1.1 criteria. A complete response was defined as the disappearance of all target lesions and non-target lesions; a partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease

Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.

Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as \[AUCt + Ct/ λz\]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

Time to Cmax, obtained directly from the observed concentration versus time data.

Terminal phase half-life in plasma, calculated as \[(ln 2)/λz\]. t1/2 was only calculated when a reliable estimate for λz could be obtained.

Apparent volume of distribution, calculated as \[(CL/F)/λz\].

Celgene

Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.

CC-486 200 mg

Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.

CC-486 300 mg

Total

Age, Continuous

Sex: Female, Male

Asian

White

Race/Ethnicity, Customized

Hispanic

Non-Hispanic or Latino

0 = Fully Active

1 = Restrictive but ambulatory

2 = Ambulatory but unable to work

3 = Limited Self-Care

ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)

Eastern Cooperative Oncology Group (ECOG) Performance Status

Time From Initial Diagnosis to First Dose

Undifferentiated Nasopharyngeal Carcinoma

Poorly Differentiated Nasopharyngeal Carcinoma

Other

The 3 types of NPC, based on how the cancer cells look under the microscope include:

1. Undifferentiated Nasopharyngeal Carcinoma
2. Poorly Differentiated Nasopharyngeal Carcinoma
3. Other

Nasopharyngeal Cancer (NPC) Diagnosis Types

The Safety Population included all participants who received at least

1 dose of investigational product (IP)

Participants with Prior Anti-Cancer Therapies

Enrolled Population: The Enrolled Population included all participants who were enrolled to the study.

The review of the efficacy data from the trial participants did not support proceeding to Stage 2 as the protocol-defined criteria of \> 4 responders (a best response of CR or PR) in Stage 1 was not reached and study enrollment was stopped.

Anne McClain, Senior Manager, Clinical Trial Disclosure

The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.

Percentage of Participants Who Achieved a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Based on an Independent Radiology Assessment (IRA)

Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria

Kaplan Meier Estimate of Overall Survival

Efficacy Evaluable Population = enrolled participants who met eligibility criteria and either received 2 cycles of IP at any dose and discontinued treatment for progressive disease or received 4 cycles of IP and had at least 2 post-screening tumor exams.

Percentage of Participants With Stable Disease for ≥ 16 Weeks From the Date of the First Treatment, or CR or PR According to RECIST 1.1 Criteria and Based on an Independent Radiology Assessment

Any TEAE

Any TEAE Related to IP

Any Serious TEAE

Any Serious TEAE Related to IP

Any CTCAE Grade 3 or 4 TEAE

Any CTCAE Grade 3 or 4 TEAE Related to IP

Any TEAE Leading to Death

Any TEAE Leading to Dose Reduction

Any TEAE Leading to Drug Interruption

Any TEAE Leading to IP Discontinuation

The Safety Population included all participants who received at least 1 dose of IP.

Number of Participants With Treatment Emergent Adverse Events

Cycle 1 Day 1

Cycle 1 Day 14

The PK population includes participants with evaluable CC-486 plasma PK profiles.

Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)

Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486

The PK population includes participants with evaluable CC-486 plasma PK profiles

Maximum Observed Concentration (Cmax) Of CC-486

Time to Reach Maximum Concentration (Tmax) Of CC-486

Terminal Half-Life (t1/2) of CC-486

Apparent Total Clearance (CL/F) Of CC-486

Apparent Volume of Distribution (Vz/F) Of CC-486

Treatment Period

Follow-Up Survival Period

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Squamous Cell

Laryngeal Diseases

Squamous Cell Carcinoma of Head and Neck

Bernd Kremer, MD, PhD

Bernd Lethaus, MD, PhD

Ernst-Jan Speel, MD, PhD

The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.

This is a prospective, non-interventional longitudinal study in patients with HNSCC. Patients will have their normal routine workup including the standard panendoscopy, during which usually multiple biopsies for diagnostic histo-pathology are obtained. Part of one of these biopsies will be stored in the HN Tumor Biobank. There will be no change in the subsequent proposed treatment, which may consist of primary surgery (with or without postoperative (chemo-) radiation) or definitive (chemo-) radiation.

The primary and general objective of this project is to develop, validate, and improve predictive models for different endpoints that are relevant for patients after curatively intended treatment of HNSCC. These endpoints include loco-regional tumour control and overall survival.

Primary Objective: To build a biobank of tumor tissue from all HNSCC patients for future genomic analyses.

Secondary Objective: To improve the outcome prediction, based on both clinical factors and tumour gene expression profiles.

Hypothesis:

Our general hypothesis is that a more accurate estimation of locoregional control and overall survival can be achieved when prognostic factors are taken into account different from than the currently used 'classical' prognostic factors, such as TNM-stage.

The investigators hypothesize that the final outcome of this project will allow us to improve the performance of predictive models for HNSCC. The performance of our prediction models will be quantified by AUC for binary outcome measures and with the c-statistic for survival analysis. The ultimate objective will be to achieve an AUC of at least 0.90. Such a performance will allow us to build a Decision Support System based on these predictive models that provides information to physicians with regard to the probability of loco-regional failure and overall survival in individual patients.

Study parameters/endpoints:

Because no specific gene-signature has yet been defined that is applicable to a large population of HNSCC patients, no specific endpoint can be named.

However, the main study endpoint will be the accuracy of a certain gene-signature that may contribute or rather improve the outcome prediction of patients. Outcome is defined as locoregional control and/or survival. The outcome of the patients is currently recorded in the electronic medical charts of azM and of Maastro Clinic and at the time of analysis, these clinical outcome data will be coupled blinded to the data generated from the tumor-biopsy analysis The goal is to achieve an AUC of at least 0.90. Such a performance will allow us to build a Decision Support System.

mucosal HNSCC oropharynx, hypopharynx, larynx, nasopharynx, oral cavity

The Head and Neck Tumor Biobank

Storage of Head and Neck Tumor Samples in a Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction: " The Head and Neck Tumor Biobank".

Maastricht Radiation Oncology

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

gemcitabine

150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

paclitaxel

Omer Kucuk, MD

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

OBJECTIVES:

* Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
* Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Gemcitabine and Paclitaxel

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.

Age Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Lip/Oral Cavity

Nasopharynx

Oropharynx

Salivary glands

Hypopharynx

Larynx

Paranasal Sinuses

Other/Unknown

Primary Site

Newly Diagnosed

Persistent

Recurrent

Not Reported

Disease Status

Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.

Performance Status

Study Statistician

All eligible patients who started treatment were included in this measure.

Progression-free Survival

Overall Survival

Complete Response

Partial Response

Unconfirmed Complete Response

Unconfirmed Partial Response

Stable/No Response

Increasing Disease

Assessment Inadequate

All eligible patients with measurable disease who started treatment were included in response measures.

Response

Allergic reaction/hypersensitivity

Anorexia

Dehydration

Diarrhea

Dyspnea (shortness of breath)

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Glucose, serum-high (hyperglycemia)

Hemoglobin

Hemorrhage, pulmonary/upper respiratory - Nose

Hypotension

Inf (clin/microbio) w/Gr 3-4 neuts - Lung

Inf w/normal ANC or Gr 1-2 neutrophils - Catheter

Inf w/normal ANC or Gr 1-2 neutrophils - Lung

Leukocytes (total WBC)

Lymphopenia

Memory impairment

Mucositis/stomatitis (functional/symp) - Oral cav

Muscle weakness, not d/t neuropathy - body/general

Neuropathy: motor

Neuropathy: sensory

Neutrophils/granulocytes (ANC/AGC)

Pain - Bone

Pain-Other (Specify)

Platelets

Pneumonitis/pulmonary infiltrates

Rash/desquamation

Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma	NCT02269943	Nasopharyngeal ...	CC-486	18 Years -	Celgene
The Head and Neck Tumor Biobank	NCT01644786	Head and Neck S...		18 Years -	Maastricht Radiation Oncology
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma	NCT02269943	Nasopharyngeal ...	CC-486	18 Years -	Celgene
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer	NCT00100789	Head and Neck C...	gemcitabine paclitaxel	18 Years -	SWOG Cancer Research Network
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck	NCT02158234	Squamous Cell C...	Cisplatin Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma	NCT03795610	Head and Neck S... Head and Neck C... Head and Neck C... Head and Neck C... Head and Neck C... HPV-Related Car... HPV-Related Mal... HPV-Related Squ...	IPI-549	18 Years -	University of California, San Diego
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck	NCT02158234	Squamous Cell C...	Cisplatin Stereotactic Bo...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
The Head and Neck Tumor Biobank	NCT01644786	Head and Neck S...		18 Years -	Maastricht Radiation Oncology
Dysphagia Assessment After Swallowing Sparing RadioTherapy	NCT03448341	Cancer of Oroph... Cancer of Nasop...		18 Years - 80 Years	Azienda Ospedaliero, Universitaria Pisana
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer	NCT00101582	Mucositis Solid Tumors Stomatitis Head and Neck C... Squamous Cell C...	Placebo palifermin cisplatin chemo... Radiotherapy	18 Years -	Swedish Orphan Biovitrum
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer	NCT00100789	Head and Neck C...	gemcitabine paclitaxel	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for nasopharynx

Every month we try and update this database with for nasopharynx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nasopharynx

Every month we try and update this database with for nasopharynx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nasopharynx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.