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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-04308 | |||
| CA 225314 | |||
| 112008-004 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: Chemotherapy with Concurrent Radiation therapy | Experimental | Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Drug | cetuximab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute and Late Toxicities | Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia. | 6 months within the end of treatment |
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DISEASE CHARACTERISTICS:
Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
Recurrent disease or second primary SCC
Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)
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:
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
No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States | ||
| Baylor Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29346519 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Chemotherapy With Concurrent Radiation Therapy | Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | cisplatin |
|
|
| intensity-modulated radiation therapy | Radiation | IMRT |
|
|
| Nab-Paclitaxel | Drug | Nab-Paclitaxel |
|
|
| Dallas |
| Texas |
| 75204 |
| United States |
| University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Three patients withdrew from the study prior to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Chemotherapy With Concurrent Radiation Therapy | Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One patient receiving treatment did not complete the entire course of systemic therapy | Median | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | One patient receiving treatment did not complete the entire course of systemic therapy | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | One patient receiving treatment did not complete the entire course of systemic therapy | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 year from the date of enrollment |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute and Late Toxicities | Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia. | Posted | Count of Participants | Participants | 6 months within the end of treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Chemotherapy With Concurrent Radiation Therapy | Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT) | 0 | 33 | 21 | 33 | 10 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Dermatitis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | General disorders | Non-systematic Assessment |
| ||
| pain | General disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Other electrolyte abnormalities | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Hyponatremia | General disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucien Nedzi | UT Southwestern Medical Center | 214-645-7653 | lucien.nedzi@utsouthwestern.edu |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D018289 | Carcinoma, Verrucous |
| D002294 | Carcinoma, Squamous Cell |
| D009062 | Mouth Neoplasms |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D009059 | Mouth Diseases |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D004358 | Drug Therapy |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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| Male |
|
|