Study on Sorafenib with Carboplatin and Paclitaxel for Treating Advanced or Returning Head and Neck Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00494182

Provider View

This clinical trial is testing a combination of drugs, including sorafenib, carboplatin, and paclitaxel, to see how well they work together in treating head and neck cancer that has spread or come back after treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of sorafenib, carboplatin, and paclitaxel can effectively stop the growth of head and neck cancer that has either spread to other parts of the body or returned after treatment. These drugs work in different ways to kill cancer cells, stop them from dividing, or prevent them from spreading.

Description

The main goal of this study is to see how long patients can live without their cancer getting worse when treated with sorafenib, carboplatin, and paclitaxel. Researchers will also look at how well the cancer responds to the treatment, the safety of the drugs, and how long patients live overall.

Participants will receive carboplatin through an IV for 30 minutes and paclitaxel through an IV for 3 hours on the first day. They will take sorafenib pills twice a day from the second day to the nineteenth day. This cycle repeats every 21 days for up to 6 cycles. Starting with the seventh cycle, participants will take sorafenib daily as long as the cancer does not progress or cause unacceptable side effects.

After finishing the study treatment, participants will have follow-up visits between 21 and 35 days later.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form before starting the study.
  • Must have a confirmed diagnosis of head and neck squamous cell cancer that has come back or spread, from areas like the mouth, voice box, throat, or lower throat.
  • No previous chemotherapy for cancer that has spread, unless it was part of initial treatment and completed at least 6 months ago.
  • Must have at least one tumor that can be measured by a CT or MRI scan.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have controlled blood pressure and meet specific blood test requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after.
  • Men must agree to use effective birth control during the study and for 3 months after.

Exclusion Criteria

  • Have severe heart problems or uncontrolled high blood pressure.
  • Have a history of HIV or chronic hepatitis B or C.
  • Have active serious infections or brain-related diseases.
  • Have a history of blood clots or bleeding disorders.
  • Have severe nerve damage or have received certain cancer treatments recently.
  • Have had major surgery or serious injuries recently.
  • Are pregnant or breastfeeding.
  • Have substance abuse issues or other conditions that could interfere with the study.
  • Have allergies to the study drugs or similar medications.
  • Are taking certain medications that could interfere with the study.
  • Are eligible for surgery or radiation that could cure the cancer.
  • Have had another type of cancer recently, except for certain non-threatening cancers.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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