Head and Neck Cancer
Conditions
Brief summary
To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)
Interventions
DRUGOxaliplatin, 5-FU
Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs.
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage III-IV) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used \< or=to 300 mg/m² or carboplatinum total dose used \< or=to 200mg/m²), at least 1 target lesion (measurable in 2 dimensions \> or=to 20 mm on computed tomography (CT) or magnetic resonance imaging (MRI) evaluated \< 15 days before start of study treatment, outside of irradiated fields),performance status (PS) \< or =to 2 World Health Organization (WHO), weight loss \< 5% normal weight,hemoglobin \> or =to 10 g/dL, neutrophils \> or =to 2000/mm3, platelets \> or =to 100,000/mm3 , creatinine \< or =to 1.5 x upper limit of normal (ULN), bilirubin \< or =to .5 x ULN, alanine amino-transferase (ALT)/aspartate amino-transferase (AST)\< or =to 2.5 x ULN (5 x ULN if liver metastases), clotting: prothrombin time (PT) \> or =to 60%. Written informed consent signed by patient and doctor prior to all study procedures -
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival) | — |
Countries
France
Outcome results
None listed