Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sinus Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Carboplatin

Cisplatin

Tubulin Modulators

Antimitotic Agents

Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Image Guided Radiation Therapy

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Questionnaire Administration

Therapeutic Conventional Surgery

Site Public Contact

Christopher Le

Jay W. Carlson

Peter H. Hwang

Harlan A. Pinto

Barbara A. Burtness

Ruben Carmona

Christine H. Chung

Dong M. Shin

John M. Schallenkamp

Vamsi K. Vasireddy

Michael J. Jelinek

Nicholas P. Campbell

Joshua Lukenbill

Neal E. Dunlap

Paul L. Swiecicki

Ding Wang

Ammar Sukari

Preston D. Steen

Douglas R. Adkins

Marc Cohen

Maged Ghaly

Balazs Halmos

Anurag K. Singh

Nabil Saba

This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.

PRIMARY OBJECTIVES:

I. Evaluate the structure preservation rate for patients with locally advanced resectable nasal and paranasal sinus squamous cell carcinoma (NPNSCC) with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care.

II. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care.

SECONDARY OBJECTIVES:

I. Evaluate progression-free survival (PFS) for this patient population. II. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration).

III. Evaluate site reported p16 data and correlate with outcome. IV. Determine the accuracy of baseline/post-chemotherapy magnetic resonance imaging (MRI) and fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation.

V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival.

TERTIARY OBJECTIVES:

I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events \[both clinical and hematologic\] and dose modifications).

II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.

III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization.

IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided intensity modulated radiation therapy (IMRT) once daily (QD) for 5 fractions per week for 30 fractions. Patients with positive margins/positive extracapsular spread (ECS) in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin intravenously (IV) over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if \< 2 years from study entry and then every 6 months if 2-5 years from study entry.

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

Phase II Randomized Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)

Fisher?s exact test will be used to compare the structure preservation rate between the two arms. The comparison between the two arms for structure preservation will be conducted separately (each at one-sided 0.05 significance level).

Log rank test will be used to compare OS between the two arms. The comparison between the two arms for OS will be conducted separately (each at one-sided 0.05 significance level).

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Symptoms and General Pathology

Mouth and Tooth Diseases

Digestive System Diseases

Recurrence

Head and Neck Neoplasms

Mouth Neoplasms

Carcinoma, Verrucous

Rectal Neoplasms

Colonic Neoplasms

Salivary Gland Neoplasms

Squamous Cell Carcinoma of Head and Neck

Disease Attributes

Neoplasms, Squamous Cell

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Tongue Cancer

Antibodies

Antibodies, Monoclonal

Cetuximab

Lenalidomide

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive lenalidomide PO QD on days 1-21 and cetuximab IV over 1-2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Erin M Bertino

This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer.

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose of lenalidomide when given in combination with cetuximab in patients with advanced colorectal or squamous cell head and neck cancer.

SECONDARY OBJECTIVES:

I. To evaluate response in refractory V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal and head/neck cancers as monitored by measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

II. To measure antibody-dependent cytotoxic activity (ADCC) in patients receiving lenalidomide plus cetuximab.

III. To measure natural killer cell cytokine production in patients receiving lenalidomide plus cetuximab.

IV. To describe fragment c gamma receptor polymorphisms. (Exploratory) V. To describe baseline immune cell function. (Exploratory)

OUTLINE: This is a dose-escalation study of lenalidomide.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and cetuximab intravenously (IV) over 1-2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 weeks.

Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

Enhancement of Cetuximab-Induced Antibody-Dependent Cellular Cytotoxicity (ADCC) With Lenalidomide in Advanced Solid Tumors: A Phase I/IB Study

Toxicity will be classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns in each of the treatment arms.

The statistical analysis corresponding to the evaluation of patient responses in measurable disease will be descriptive in nature. The reporting of the patient responses will include a description of all patients enrolled on study as well as evaluable patients receiving at least one cycle of combination therapy with lenalidomide. The response rate analysis will include an explanation of which patients were excluded.

A bivariate plot will be used to describe the relationship between tumor shrinkage and peak ADCC and cytokine levels over time. Results will be summarized using descriptive statistics (i.e. means, medians, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery	NCT03493425	Stage III Nasal... Stage IVA Nasal...	Carboplatin Cisplatin Docetaxel Image Guided Ra... Intensity-Modul... Laboratory Biom... Questionnaire A... Therapeutic Con...	18 Years -	Eastern Cooperative Oncology Group
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery	NCT03493425	Stage III Nasal... Stage IVA Nasal...	Carboplatin Cisplatin Docetaxel Image Guided Ra... Intensity-Modul... Laboratory Biom... Questionnaire A... Therapeutic Con...	18 Years -	Eastern Cooperative Oncology Group
Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer	NCT01254617	Recurrent Colon... Recurrent Hypop... Recurrent Laryn... Recurrent Laryn... Recurrent Lip a... Recurrent Metas... Recurrent Nasal... Recurrent Nasop... Recurrent Oral ... Recurrent Oroph... Recurrent Recta... Recurrent Saliv... Salivary Gland ... Squamous Cell C... Stage IV Hypoph... Stage IV Nasoph... Stage IVA Colon... Stage IVA Laryn... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Major... Stage IVA Nasal... Stage IVA Oral ... Stage IVA Oroph... Stage IVA Recta... Stage IVB Colon... Stage IVB Laryn... Stage IVB Laryn... Stage IVB Lip a... Stage IVB Major... Stage IVB Nasal... Stage IVB Oral ... Stage IVB Oroph... Stage IVB Recta... Stage IVC Laryn... Stage IVC Laryn... Stage IVC Lip a... Stage IVC Major... Stage IVC Nasal... Stage IVC Oral ... Stage IVC Oroph... Tongue Carcinom...	Cetuximab Laboratory Biom... Lenalidomide	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iva nasal cavity and paranasal sinus squamous cell carcinoma ajcc v7