Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Vorinostat

Antimetabolites

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eric Chen

This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck cancer.

PRIMARY OBJECTIVES:

I. To determine the objective response rate (complete and partial) and duration of response of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). (SCCHN) II. To determine the objective response rate (complete and partial) and duration of response of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic nasopharyngeal carcinoma (NPC). (NPC)

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic SCCHN. (SCCHN) II. To determine the rate of progression-free survival (PFS) at 6 months. (SCCHN) III. To determine the rate and duration of stable disease (SD). (SCCHN) IV. To determine the median PFS, and the rate of PFS at 1 year. (SCCHN) V. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year. (SCCHN) VI. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic NPC. (NPC) VII. To determine the duration of objective response. (NPC) VIII. To determine the rate and duration of stable disease (SD). (NPC) IX. To determine the median PFS, and the rate of PFS at 1 year. (NPC) X. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year. (NPC)

OUTLINE: This is a non-randomized, open-label study of patients with SCCHN and NPC (Stage I), followed by a randomized study of patients with NPC (Stage II).

STAGE I: Patients receive capecitabine orally (PO) twice daily (BID) and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

STAGE II: Patients with NPC are randomized to 1 of 2 treatment arms.

ARM I: Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients will be followed up at 3-4 weeks and then every 6 months for 1 year.

Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

A Phase II Study of Vorinostat and Capecitabine in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) and Nasopharyngeal Carcinoma (NPC)

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.

PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.

National Cancer Institute (NCI)

Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Vorinostat: Given PO

Arm I (Capecitabine, Vorinostat)

Age, Categorical

Age, Continuous

Sex: Female, Male

Canada

United States

Region of Enrollment

Early termination due to lack of activity of study drug.

Dr.Eric Chen, Principal Investigator

Response Rate According to Response Evaluation Criteria in Solid Tumors

16 patients of the 25 were eligible for response assessment.

Survival

16 of 25 patients were evaluable for response.

Progression-free Survival

Overall Study

Nivolumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Jennifer Johnson, MD, PhD

This phase II trial studies how well nivolumab, carboplatin, and paclitaxel work in treating patients with stage III-IV head and neck squamous cell carcinoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, carboplatin, and paclitaxel may work better in treating patients with head and neck squamous cell carcinoma.

PRIMARY OBJECTIVES:

I. To estimate pathologic complete response (pCR) at the primary site in patients with newly diagnosed and untreated stage III-IVA squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, larynx, and hypopharynx with nivolumab, paclitaxel and carboplatin in addition to standard chemotherapy.

SECONDARY OBJECTIVES:

I. Safety. II. Complete pathologic response at all sites of disease. III. Major pathologic response rate at primary site. IV. Overall clinical response rate. V. Clinical complete response rate. VI. 1 year progression-free survival (PFS). VII. Overall survival.

TERTIARY OBJECTIVES:

I. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc.) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc.) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response.

III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy.

IV. To explore the predictive value of serial cell free deoxyribonucleic acid (DNA) levels and response.

Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Nivolumab Plus Weekly Carboplatin and Paclitaxel as Induction in Resectable Locally Advanced Head and Neck Cancer

The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.

patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response

Bristol-Myers Squibb

Sidney Kimmel Cancer Center at Thomas Jefferson University

An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Paclitaxel: Given IV

Carboplatin: Given IV

Nivolumab: Given IV

Treatment (Nivolumab, Paclitaxel, Carboplatin)

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Jennifer Johnson

The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.

Pathologic Complete Response Rate

number of patients with Major response (Major or complete) was 72.73% (24/33) with a 95% Confidence Interval of 54.2% to 86.1%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer	NCT01267240	Paranasal Sinus... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Capecitabine Vorinostat	19 Years -	National Cancer Institute (NCI)
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer	NCT01267240	Paranasal Sinus... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Capecitabine Vorinostat	19 Years -	National Cancer Institute (NCI)
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer	NCT01267240	Paranasal Sinus... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Capecitabine Vorinostat	19 Years -	National Cancer Institute (NCI)
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery	NCT03342911	Name Human Papi... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Oral ... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oral C... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Paclitaxel Carboplatin Nivolumab	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for stage ivb hypopharyngeal squamous cell carcinoma