Head and Neck, Squamous Cell Cancer
Conditions
Keywords
Head and Neck cancer, Cetuximab
Brief summary
The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.
Interventions
BIOLOGICALcetuximab
Cetuximab 500 mg/m\^2 IV over 2 hours every other week
Sponsors
Eli Lilly and Company
National Comprehensive Cancer Network
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed informed consent and HIPAA authorization * histologically confirmed squamous cell cancer of the head and neck * At least 21 days must have elapsed from the administration of prior chemotherapy for recurrent/metastatic disease. * measurable disease as defined by RECIST * ECOG PS ≤ 2 * Adequate hematologic function as defined by an ANC \> or = to 1200/mm3 , and a platelet count ≥ 100,000 obtained within 14 days prior to enrollment. * Adequate hepatic function as defined by t. bilirubin ≤ 1.5 mg/dl, transaminases & alk phos ≤ 5x ULN obtained within 14 days prior to enrollment. * Adequate renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance \>40 mL/minute. * Women of childbearing potential must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study and have a negative pregnancy test within 7 days prior to registration. If a male and sexually active, the patient agrees to use effective contraception. * Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center. * Patients with treated CNS metastases may be eligible if they have fully recovered from radiation therapy, surgery or steroids that were prescribed for CNS metastases.
Exclusion criteria
* Known, uncontrolled CNS metastases. CT/MRI of the brain is not required unless CNS metastases are suspected clinically. * prior cetuximab therapy in the setting of recurrence or refractory disease * Other active invasive malignancies, other than non-melanoma skin cancers or in situ cervical cancer. * Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, or targeted therapy. * Ongoing or active clinically serious infection \> CTCAE Grade 2 requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia,(patients with stable rate-controlled atrial fibrillation may be eligible) or other medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study, or psychiatric illness/social situations that would limit compliance with study requirements. * elective or planned major surgery to be performed during the course of the trial * pregnant or lactating women * employees of the investigator or study center w/ direct involvement in this study or other studies under the direction of the or study center, as well as family member of the employees * More than two prior cytotoxic regimens for metastatic/recurrent disease. * Known hypersensitivity reaction to mouse antibodies. * Patients with nasopharyngeal cancer are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Overall Objective Response | Approximately every 8 weeks with imaging up to two years | Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Total Number of Participants That Were Effected by Adverse Events. | at least weekly | Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A Cetuximab infusion at 500 mg/m2 over 2 hours every other week. | 35 |
| Arm B Cetuximab infusion at 750 mg/m2 over 3 hours every other week. | 26 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Patient not treated | 0 | 2 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 28 Participants | 24 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 30 | 18 / 19 |
| serious Total, serious adverse events | 18 / 30 | 7 / 19 |
Outcome results
Primary
Number of Patients With Overall Objective Response
Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam
Time frame: Approximately every 8 weeks with imaging up to two years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Number of Patients With Overall Objective Response | Partial Response (PR) | 4 participants |
| Arm A | Number of Patients With Overall Objective Response | Stable Disease (SD) | 12 participants |
| Arm A | Number of Patients With Overall Objective Response | Progression of Disease (POD) | 14 participants |
| Arm B | Number of Patients With Overall Objective Response | Partial Response (PR) | 2 participants |
| Arm B | Number of Patients With Overall Objective Response | Stable Disease (SD) | 5 participants |
| Arm B | Number of Patients With Overall Objective Response | Progression of Disease (POD) | 12 participants |
Secondary
The Total Number of Participants That Were Effected by Adverse Events.
Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.
Time frame: at least weekly
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | The Total Number of Participants That Were Effected by Adverse Events. | 28 Participants |
| Arm B | The Total Number of Participants That Were Effected by Adverse Events. | 18 Participants |