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Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Oxaliplatin, 5-FU

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

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 Outcome Measures

To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

Full Information

NCT ID

NCT00611754

First Posted

January 28, 2008

Last Updated

January 28, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00611754

Brief Title

Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

Official Title

Phase II Study of Oxaliplatin in Combination With 5-Fluorouracil (5-FU) in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin, 5-FU

Other Intervention Name(s)

Eloxatin®, Fluorouracil

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathalie Billon

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

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