Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00494182

Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Clinical Trial Summary

This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN). SECONDARY OBJECTIVES: I. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival. OUTLINE: Participants receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib orally (PO) twice daily (BID) on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up between 21-35 days. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Squamous Cell Carcinoma of the Hypopharynx
  • Metastatic Squamous Cell Carcinoma of the Larynx
  • Metastatic Squamous Cell Carcinoma of the Oral Cavity
  • Metastatic Squamous Cell Carcinoma of the Oropharynx
  • Neoplasms, Squamous Cell
  • Recurrence
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT00494182
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 25, 2007
Completion date December 31, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03468218 - Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Phase 2
Recruiting NCT05945875 - Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer Phase 1
Completed NCT03229278 - Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma Phase 1
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT01468896 - Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery Phase 1/Phase 2
Recruiting NCT04862650 - Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Terminated NCT01602315 - A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Recruiting NCT05726370 - Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC Phase 2
Terminated NCT03823131 - Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat Phase 2
Terminated NCT03522584 - Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Withdrawn NCT04834349 - Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer Phase 2
Completed NCT04220775 - Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2
Recruiting NCT05063552 - Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers Phase 2/Phase 3
Recruiting NCT04588038 - NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery Phase 1
Withdrawn NCT05359692 - INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT04282109 - Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX) Phase 2
Active, not recruiting NCT03521570 - Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer Phase 2
Recruiting NCT05156970 - Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC Phase 2