Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401323
Other study ID # EFC6051
Secondary ID XRP6976G-322
Status Completed
Phase Phase 2/Phase 3
First received November 17, 2006
Last updated January 19, 2011
Start date January 1998
Est. completion date June 2003

Study information

Verified date January 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.


Recruitment information / eligibility

Status Completed
Enrollment 568
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
docetaxel (XRP6976)

cisplatin

5-fluorouracil (5-FU)


Locations

Country Name City State
Argentina Sanofi-Aventis Buenos Aires
Australia sanofi-aventis, Australia Macquarie Park New South Wales
Austria Sanofi-Aventis Vienna
Belgium sanofi-aventis, Belgium Diegem
Brazil Sanofi-Aventis Rio de Janeiro
Canada sanofi-aventis Canada Laval Quebec
France sanofi-aventis, France Paris
Germany sanofi-aventis Germany Berlin
Greece sanofi-aventis Greece Athens
Guadeloupe Sanofi-Aventis Basse-Terre
Hungary Sanofi-Aventis Hungaria Budapest
Israel sanofi-aventis Israel Natanya
Italy sanofi-aventis Italy Milano
Réunion Sanofi-Aventis Saint-Denis
Russian Federation Sanofi-Aventis Moscow
South Africa sanofi-aventis South Africa Midrand
Spain Sanofi-Aventis Madrid
Switzerland sanofi-aventis Switzerland Geneva
United States sanofi-aventis US Bridgewater New Jersey
Uruguay Sanofi-Aventis Montevideo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Greece,  Guadeloupe,  Hungary,  Israel,  Italy,  Russian Federation,  Réunion,  South Africa,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to progression up to 5 years No
Secondary overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure up to 5 years No
See also
  Status Clinical Trial Phase
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03775980 - CIRSE Emprint Microwave Ablation Registry
Completed NCT01114958 - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases Phase 1
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT04458259 - Study of PF-07265807 in Participants With Metastatic Solid Tumors. Phase 1
Completed NCT01218542 - Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc N/A
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Active, not recruiting NCT02395224 - A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Recruiting NCT01960829 - Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study Phase 2
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Recruiting NCT01564810 - Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer Phase 4
Completed NCT00375245 - Rapamycin With Grapefruit Juice for Advanced Malignancies Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00207116 - An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma Phase 1
Completed NCT00207103 - MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT00172003 - Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis Phase 4