A Phase 2 interventional study of cetuximab C225 and cisplatin in Head and Neck Cancer, sponsored by Eastern Cooperative Oncology Group. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy 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 locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to tumor site (hypopharynx vs. oropharynx vs. oral cavity vs. larynx), primary tumor stage (T1-3 vs. T4), and nodal status (N0 vs. N1 vs. N2-3).
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 10 years.
ACCRUAL: A total of 69 patients were accrued for this study.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 69 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland)
Unresectable disease
Meets the following criteria for unresectable disease by tumor site:
Hypopharynx, meeting 1 of the following criteria:
Larynx
Oral cavity
Base of tongue, meeting 1 of the following criteria:
Tonsillar area, meeting 1 of the following criteria:
Adequate hematologic, renal, and hepatic function obtained \<=4 weeks prior to registration
Exclusion Criteria:
* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
Biological: cetuximab C225 · Drug: cisplatin · Radiation: radiation therapy
400 mg/m\^2 IV over 120 minutes on Day 1, 250 mg/m\^2 IV over 60 minutes on Day 8, then weekly
Also known as: Cetuximab, Erbitux
75 mg/m\^2 IV over 30-60 minutes starting day 15 every 3 weeks \* 3 (Days 1, 22, and 43 of radiation therapy (RT))
Also known as: Platinol, Platinol-AQ, CDDP, DDP, DACP, Platinum, cis-Platinum
RT 70 Gy / 35 starting Day 15, 200cGy / d \* 7 weeks (35 fractions)
2-year Progression-free Survival Rate
Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.
Time frame: assessed every 3 months for 2 years
2-year Overall Survival Rate
Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.
Time frame: assessed very 3 months for 2 years
Overall Response Rate
Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients
Time frame: assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry
The study was open to accrual on 12/21/2004, accrued its first patient on April 8, 2005, and was closed on 07/20/2006. The final accrual was 69 patients.
| Milestone | Cisplatin, C225, Radiation |
|---|---|
| Started | 69 |
| Began protocol therapy | 66 |
| Eligible and treated | 60 |
| Completed | 7 |
| Not completed | 62 |
| Withdrew: Lack of efficacy | 9 |
| Withdrew: Adverse event | 15 |
| Withdrew: Death | 6 |
| Withdrew: Withdrawal by subject | 15 |
| Withdrew: Not started protocol therapy | 3 |
| Withdrew: Ineligible | 6 |
| Withdrew: Other reason | 8 |
Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.
| proportion of participants | Cisplatin, C225, Radiation |
|---|---|
| 2-year Progression-free Survival Rate | 47 (33 to 61) |
Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.
| proportion of participants | Cisplatin, C225, Radiation |
|---|---|
| 2-year Overall Survival Rate | 66 (54 to 78) |
Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients
| proportion of participants | Cisplatin, C225, Radiation |
|---|---|
| Overall Response Rate | 66.7 (55.3 to 76.7) |
Collected over Assessed weekly while on treatment, and every 3 months for 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cisplatin, C225, Radiation | — | 64/66 (97%) | 66/66 (100%) |
| Event | Cisplatin, C225, Radiation |
|---|---|
| Muco/stomatitis (symptom) oral cavityGastrointestinal disorders | 36/66 |
| DysphagiaGastrointestinal disorders | 30/66 |
| AnorexiaMetabolism and nutrition disorders | 23/66 |
| LeukopeniaInvestigations | 19/66 |
| Weight lossInvestigations | 18/66 |
| NeutropheniaInvestigations | 17/66 |
| Rash: acne/acneiformSkin and subcutaneous tissue disorders | 17/66 |
| FatigueGeneral disorders | 15/66 |
| HyponatremiaMetabolism and nutrition disorders | 14/66 |
| DehydrationMetabolism and nutrition disorders | 13/66 |
| Event | Cisplatin, C225, Radiation |
|---|---|
| AnemiaBlood and lymphatic system disorders | 60/66 |
| Muco/stomatitis (symptom) oral activityGastrointestinal disorders | 59/66 |
| Rash: ache/acneiformSkin and subcutaneous tissue disorders | 58/66 |
| Weight lossInvestigations | 57/66 |
| LeukopeniaInvestigations | 55/66 |
| FatigueGeneral disorders | 55/66 |
| NauseaGastrointestinal disorders | 50/66 |
| HypoalbuminemiaMetabolism and nutrition disorders | 49/66 |
| DysphagiaGastrointestinal disorders | 48/66 |
| HyponatremiaMetabolism and nutrition disorders | 47/66 |
| Age, Continuous(years) | Cisplatin, C225, Radiation |
|---|---|
| Median | 54.8 (42.0 to 78.5) |
| Sex: Female, Male(Participants) | Cisplatin, C225, Radiation |
|---|---|
| Female | 9 |
| Male | 51 |
| Region of Enrollment(participants) | Cisplatin, C225, Radiation |
|---|---|
| United States | 60 |
No study locations are listed for this record.
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Eastern Cooperative Oncology Group