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Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

Phase I Study of Platinum-based Chemoradiotherapy (CRT) With Oral Rigosertib in Patients With Intermediate or High-risk Head and Neck Squamous Cell Carcinoma

NCT02107235•Traws Pharma, Inc.

View on ClinicalTrials.gov

Summary

The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib that can be used with cisplatin and CRT. This study will also record any side effects that may occur and measure tumor sizes and how long patients live.

Detailed Description

This is a multicenter, dose-escalating study of oral rigosertib administered with concurrent cisplatin and Radiotherapy in patients with intermediate- and high-risk Head and Neck Squamous Cell Carcinoma. Three rigosertib escalating cohorts (up to 6 patients per cohort) will be sequentially evaluated: 70 mg 3 times a day (TID), 140 mg TID and 280 mg TID. The total treatment course will be 8 weeks: 1 week of oral rigosertib alone (70 mg TID, 140 mg TID or 280 mg TID) followed by 7 weeks of concurrent administration of rigosertib, cisplatin and radiation therapy. After completion of treatment, patients will be followed for up to 36 months to document Progression-free Survival and Overall Survival.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Pathologically confirmed diagnosis of Squamous Cell Carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal wall), hypopharynx, or larynx.
•2. Patient is an appropriate candidate for definitive chemoradiotherapy.
•3. Intermediate-risk Head and Neck Squamous Cell Carcinoma (HNSCC), defined as follows:
•1. Clinical stage T2-4, N2a-N3 or T3-4, N0-N3
•2. P16 (+) by immunohistochemistry (IHC) or HPV (+) by in situ hybridization (ISH)
•3. Smoking status of ≥ 10 pack-years, or \< 10 pack-years and T4 or N2c-N3.
•4. If not intermediate-risk HNSCC, is high-risk HNSCC, defined as follows:
•1. Clinical stage T2-4, N2a-N3 or T3-4, N0-N3.
•2. P16 (-) by IHC or HPV (-) by ISH.
•5. No evidence of distant metastases.
+8 more criteria

Exclusion Criteria

•1. Gross total excision of the primary and nodal disease.
•2. Prior treatment with IV or oral rigosertib.
•3. Prior chemotherapy for the study HNSCC cancer.
•4. Prior radiotherapy to the region of the study HNSCC cancer or adjacent anatomical sites, or to \> 25% of marrow-bearing area.
•5. Synchronous malignancies.
•6. Prior invasive malignancy unless the patient is disease-free for a minimum of 3 years; however, patients with prior non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or prostate cancer with undetectable prostate-specific antigen (PSA) may be enrolled.
•7. Severe, active comorbidity.
•8. Known infection with human immunodeficiency virus (HIV).
•9. Any uncontrolled condition that, in the opinion of the Investigator, could affect the subject's participation in the study.
•10. Major surgery within 3 weeks of enrollment or major surgery without full recovery.
+11 more criteria

Locations (4)

University of Colorado Cancer Center

Aurora, Colorado, United States

Christiana Care Health Services

Newark, Delaware, United States

Montefiore Medical Center

The Bronx, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

January 1, 2015

Last Updated

June 23, 2017

Enrollment

ACTUAL participants

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

oral rigosertib

DRUG

cisplatin

DRUG

Radiotherapy

RADIATION

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT04099290

Head and Neck NeoplasmCarcinoma, Squamous Cell

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RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069

Head and Neck Neoplasms

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RECRUITINGPHASE1

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

Inclusion Criteria

Exclusion Criteria

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Study Project in the Geriatric Population

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

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