Study on OSI-774, Cisplatin, and Taxotere for Treating Head and Neck Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00076310

Provider View

This clinical trial is testing a new treatment combination of OSI-774, cisplatin, and Taxotere to see if it can effectively treat head and neck cancer that has spread or returned. The study will also look at the safety of this treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new drug, OSI-774, when combined with chemotherapy drugs cisplatin and Taxotere, can help treat head and neck cancer that has spread or come back. OSI-774 works by blocking an enzyme that helps cancer cells grow, while cisplatin and Taxotere are chemotherapy drugs that target and destroy cancer cells. The study will also check how safe this treatment is for patients.

Description

In this study, participants will take OSI-774 by mouth once a day. Every three weeks, they will receive cisplatin and Taxotere through an IV. This treatment cycle will continue for 18 weeks. Participants will keep taking OSI-774 as long as it helps their cancer, unless they experience severe side effects or their doctor decides it's no longer beneficial.

Before starting the study, participants will have a physical exam, blood tests, heart tests, and scans to check their health and cancer status. Women who can have children must have a negative pregnancy test.

During the study, participants will have weekly blood tests and check-ups every three weeks to monitor their health and any side effects. Every six weeks, they will have imaging tests to see how the cancer is responding to treatment.

If the cancer worsens or side effects become too severe, participants will stop the study treatment and discuss other options with their doctor. Participants can continue receiving OSI-774 as long as it is effective. Regular check-ups and tests will continue every three months.

This study is investigational, meaning OSI-774 is not yet approved for this type of cancer, although it is approved for other uses. Cisplatin and Taxotere are already approved and available. The study will include 50 participants, and there will be no cost for the study drug or related tests.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic or recurrent head and neck squamous cell carcinoma.
  • Have at least one measurable tumor.
  • No prior chemotherapy for metastatic or recurrent cancer.
  • Aged 18 or older.
  • In good general health with normal organ function.
  • Agree to use effective birth control during and after the study.
  • Able to understand and sign a consent form.
  • Open to all genders and ethnic groups.

Exclusion Criteria

  • Previous chemotherapy or non-palliative radiotherapy for recurrent or metastatic cancer.
  • Currently using other investigational drugs.
  • Brain metastases.
  • Allergic reactions to similar drugs.
  • Previous treatment targeting EGFR.
  • Active infection requiring treatment.
  • Major psychiatric illness affecting consent.
  • Need for total parenteral nutrition.
  • Uncontrolled illness like heart failure or severe infection.
  • Different cancer type than squamous cell carcinoma.
  • Refusal to sign consent.
  • Severe allergy to Taxotere.
  • Severe pre-existing nerve damage.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on anti-retroviral therapy.

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