A Phase 2 interventional study of Cetuximab and Hydroxyurea in Head and Neck Cancer, Cancer of the Pharynx and Cancer of the Larynx, sponsored by Johnny Kao. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Johnny Kao · Phase 2, Interventional, and Treatment
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 33 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Johnny Kao is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
Drug: Cetuximab · Drug: Hydroxyurea · Drug: Fluorouracil · Procedure: radiotherapy
250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule. Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.
Llocoregional Recurrence
Percentage of Participants with Loco-regional recurrence.
Time frame: 2 years
Survival
Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
Time frame: 2 years
Long- Term Toxicity
Grade 3 toxicities events
Time frame: 2 years
UW-QOLR: Quality of Life Score
University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).
Time frame: 2 years
Distant Metastases
Percentage of participants who did not have distant control
Time frame: 2 years
Recruitment period January 2007 through April 2008. All cases were reviewed at a multidisciplinary conference, which was attended by representatives from the Departments of Head and Neck Surgery, Radiation Oncology, Medical Oncology, Palliative Care, Social Work, and Nutrition at Icahn School of Medicine at Mount Sinai.
| Milestone | Advanced Head and Neck Cancer |
|---|---|
| Started | 33 |
| Completed | 33 |
| Not completed | 0 |
Percentage of Participants with Loco-regional recurrence.
| Participants | Advanced Head and Neck Cancer |
|---|---|
| Llocoregional Recurrence | 27 |
Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
| percentage of participants | Advanced Head and Neck Cancer |
|---|---|
| Overall Survival | 86 |
| Disease-Free Survival | 69 |
Grade 3 toxicities events
| events | Advanced Head and Neck Cancer |
|---|---|
| Long- Term Toxicity | 32 |
University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).
| units on a scale | Advanced Head and Neck Cancer |
|---|---|
| UW-QOLR: Quality of Life Score | 80 (0 to 100) |
Percentage of participants who did not have distant control
| percentage of participants | Advanced Head and Neck Cancer |
|---|---|
| Distant Metastases | 21 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Advanced Head and Neck Cancer | — | 33/33 (100%) | 33/33 (100%) |
| Event | Advanced Head and Neck Cancer |
|---|---|
| PainGeneral disorders | 14/33 |
| MucositisGastrointestinal disorders | 11/33 |
| Low White blood countBlood and lymphatic system disorders | 6/33 |
| Low Hemoglobin countBlood and lymphatic system disorders | 6/33 |
| DermatitisSkin and subcutaneous tissue disorders | 5/33 |
| Low Absolute neutrophil countBlood and lymphatic system disorders | 4/33 |
| Low Platelets countBlood and lymphatic system disorders | 1/33 |
| Event | Advanced Head and Neck Cancer |
|---|---|
| XerostomiaGeneral disorders | 33/33 |
| DermatitisSkin and subcutaneous tissue disorders | 28/33 |
| Low White blood countBlood and lymphatic system disorders | 25/33 |
| Low Hemoglobin countBlood and lymphatic system disorders | 25/33 |
| MucositisGastrointestinal disorders | 22/33 |
| PainGeneral disorders | 19/33 |
| Low Absolute neutrophil countBlood and lymphatic system disorders | 18/33 |
| Low Platelet countBlood and lymphatic system disorders | 8/33 |
| Age, Continuous(years) | Advanced Head and Neck Cancer |
|---|---|
| Median | 59 (18 to 77) |
| Sex: Female, Male(Participants) | Advanced Head and Neck Cancer |
|---|---|
| Female | 9 |
| Male | 24 |
| Race/Ethnicity, Customized(participants) | Advanced Head and Neck Cancer |
|---|---|
| White | 23 |
| Black | 5 |
| Hispanic | 5 |
| Asian | 0 |
| Performance score(participants) | Advanced Head and Neck Cancer |
|---|---|
| 0 | 12 |
| 1 | 19 |
| 2 | 2 |
| Charlson comorbidity score(participants) | Advanced Head and Neck Cancer |
|---|---|
| 0-1 | 27 |
| ≥2 | 6 |
| Alcohol consumption(participants) | Advanced Head and Neck Cancer |
|---|---|
| None | 10 |
| Occasional | 14 |
| Moderate | 2 |
| Heavy | 7 |
| Smoking(participants) | Advanced Head and Neck Cancer |
|---|---|
| None | 6 |
| Cigar, pipe, or betel nut only | 3 |
| ≤20 pack-y | 9 |
| 20.1-40 packk-y | 7 |
| >40 pack-y | 8 |
| Primary site(participants) | Advanced Head and Neck Cancer |
|---|---|
| Sinonasal | 2 |
| Nasopharynx | 2 |
| Oropharynx | 14 |
| Oral cavity | 6 |
| Salivary gland | 1 |
| Larynx | 2 |
| Hyopharynx | 4 |
| Unknown primary | 2 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Johnny Kao