Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

NCT00833261 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000632295SCCC-04308CA 225314112008-004
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

recurrent hypopharynx Cancer; recurrent larynx Cancer; recurrent verrucous carcinoma; squamous cell carcinoma; recurrent oral cavity cancer; recurrent metastatic occult primary cancer; recurrent oropharynx cacner; recurrent paranasal sinus and nasal cavity cancer; tongue cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.

  2 year from the date of enrollment

Secondary Outcomes (1)

• Number of Participants With Acute and Late Toxicities

  6 months within the end of treatment

Study Arms (1)

Single Arm: Chemotherapy with Concurrent Radiation therapy

EXPERIMENTAL

Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy

Drug: cetuximab; Drug: cisplatin; Radiation: intensity-modulated radiation therapy; Drug: Nab-Paclitaxel

Interventions

cetuximab DRUG

cetuximab

Also known as: chemo

Single Arm: Chemotherapy with Concurrent Radiation therapy

cisplatin DRUG

cisplatin

Also known as: chemo

Single Arm: Chemotherapy with Concurrent Radiation therapy

intensity-modulated radiation therapy RADIATION

IMRT

Also known as: IMRT

Single Arm: Chemotherapy with Concurrent Radiation therapy

Nab-Paclitaxel DRUG

Nab-Paclitaxel

Also known as: chemo

Single Arm: Chemotherapy with Concurrent Radiation therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract * Recurrent disease or second primary SCC * Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) * Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy * More than one recurrence allowed provided the first recurrence occurred \> 6 months after the completion of prior radiotherapy * Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) * No signs of carotid exposure * No primary nasopharyngeal or salivary gland tumor * Equivocal pulmonary nodes on chest CT scan allowed provided they are \< 1 cm, cannot be safely biopsied, or are negative on PET scan * No distant metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) * Bilirubin \< 1.5 mg/dL * AST or ALT \< 2 times upper limit of normal * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded * No active cardiac disease, including any of the following: * Unstable angina * Uncontrolled hypertension * Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) * Uncontrolled arrhythmia * Congestive heart failure * At least 3 heart-related hospitalizations within the past year * No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year * No concurrent medical illness that would impair patient tolerance to therapy or limit survival * No other invasive malignancy within the past 2 years * No pre-existing peripheral sensory neuropathy ≥ grade 2 * No prior severe infusion reaction to a monoclonal antibody * No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * Prior cisplatin and cetuximab allowed * At least 6 months since prior radiotherapy or chemotherapy * No prior radiotherapy \> 75 Gy * No prior chemotherapy for recurrent head and neck cancer * Prior chemotherapy as a component of the primary treatment allowed * No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer * Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been \> 6 months since treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (4)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Awan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.

  PMID: 29346519 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma, Verrucous; Carcinoma, Squamous Cell; Mouth Neoplasms; Tongue Neoplasms

Interventions

Cetuximab; Drug Therapy; Cisplatin; Radiotherapy, Intensity-Modulated; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Mouth Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Results Point of Contact

• Title: Dr. Lucien Nedzi
• Organization: UT Southwestern Medical Center

lucien.nedzi@utsouthwestern.edu

214-645-7653

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2016
• Last Updated: August 21, 2020
• Results First Posted: July 5, 2019

Record last verified: 2018-11

Locations

US (4)