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Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT00736619•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein. Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage III-IVB)
•Karnofsky performance status ≥ or = to 70%
•Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl, platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl
•Adequate hepatic function:
•Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used
•Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method
•Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
•Women of childbearing potential must have a negative pregnancy test
•Patients must have ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

•Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll
•Prior radiation therapy for head and neck cancer
•Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
•Inability to comply with study and/or follow-up procedures
•Women who are pregnant or lactating
•Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina, auto-immune connective tissue disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
•History of severe infusion reaction to a monoclonal antibody

Locations (5)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

August 10, 2016

Enrollment

ACTUAL participants

Conditions

HEAD & NECK Cancer

Interventions

Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)

OTHER

Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer

NCT07285564

Head & Neck Cancer

View study

NOT_YET_RECRUITINGPHASE3

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

NCT07445048

Head & Neck Squamous Cell CarcinomaHead & Neck Cancer+1 more

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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: August 10, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions

Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

Inclusion Criteria

Exclusion Criteria

Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

SL-28 for Advanced Solid Tumours

Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma

PCA062 in pCAD-positive Tumors.