Carcinoma, Squamous, Head and Neck Cancer
Conditions
Keywords
cancer, head and neck cancer, squamous cell cancer
Brief summary
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size
Detailed description
This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.
Interventions
DRUGOxaliplatin
130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
DRUGDocetaxel
60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
DRUGCetuximab
400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Sponsors
Sanofi
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed recurrent SCCHN * 18 years or older * Tumor site accessible by biopsy * Measurable disease * Receiving no other therapy * ECOG performance status 0-1 * Adequate bone marrow, renal function and hepatic function
Exclusion criteria
* Active infection or fever within 3 days of treatment * Active CNS metastases * Prior malignancy within 5 years * Hypersensitivity to study drugs * Chemotherapy within 30 days of treatment * Concurrent investigational therapy within 30 days * Radiotherapy of more than 25% of bone marrow * Peripheral neuropathy of grade 2 or greater * Pregnant or lactating patients * History of allogeneic transplant * Active or previously treated HIV or Hepatitis B or C * Patients with a tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Measured by Response Rate in Participants | 12 Weeks, 1 Year | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxalipatin and Docetaxel Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Oxalipatin and Docetaxel |
|---|---|
| Age, Continuous | 66 years |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 10 / 16 |
Outcome results
Primary
Efficacy Measured by Response Rate in Participants
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: 12 Weeks, 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxaliplatin and Docetaxel | Efficacy Measured by Response Rate in Participants | Complete Response | 0 participants |
| Oxaliplatin and Docetaxel | Efficacy Measured by Response Rate in Participants | Partial Response | 2 participants |
| Oxaliplatin and Docetaxel | Efficacy Measured by Response Rate in Participants | Stable Disease | 6 participants |
| Oxaliplatin and Docetaxel | Efficacy Measured by Response Rate in Participants | Progressive Disease | 3 participants |
| Oxaliplatin and Docetaxel | Efficacy Measured by Response Rate in Participants | Not Evaluable | 5 participants |