Head and Neck Neoplasms, Neoplasms
Conditions
Keywords
Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II
Brief summary
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.
Detailed description
Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.
Interventions
DRUGOxaliplatin and Docetaxel
Chemotherapy Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.
Sponsors
Sanofi
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
NON_RANDOMIZED
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 metastatic or locoregionally recurrent SCCHN deemed incurable by local therapy * Measureable disease * No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy * No prior treatment with oxaliplatin or docetaxel * 18 years of age or older * ECOG Performance status 0-1 * ANC 1,500/mcl or greater * Adequate renal function * Adequate liver function * Recovered from acute and late effects of any prior treatment with a minimum of 4 weeks from the last session to enrollment in the study * Patient or their legal representative must be able to read, understand, and provide informed consent * Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication
Exclusion criteria
* Patients with an active documented infection or with a fever (38.5 degrees celsius or higher) within 3 days of the first scheduled dose of study treatment * Patients with active CNS metastases * Hypercalcemia related to SCCHN * History of prior malignancy with the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate cancer * Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel or to other drugs formulated with polysorbate 90 * Patients receiving concurrent investigational therapy or investigational therapy less than 30 days from first scheduled dose of study therapy * Peripheral neuropathy grade 2 or higher * Any medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results * History of allogeneic transplant * Known HIV or Hepatitis B or C (active, previously treated or both)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as determined by RECIST criteria every 6 weeks. | 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity and Quality of Life assessments every 3 weeks. | 2 years |
Countries
United States
Outcome results
None listed