Study on Paclitaxel, Carboplatin, and Cetuximab with Cetuximab, Docetaxel, Cisplatin, and Fluorouracil for Untreated Advanced Head and Neck Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01154920

Provider View

This clinical trial is comparing two different chemotherapy combinations to see which is more effective in treating advanced head and neck cancer. The study will also look at the side effects of these treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out which combination of chemotherapy drugs works better for treating advanced head and neck cancer. The study will also examine the side effects of these treatments. Participants will receive chemotherapy in two parts: the first part involves chemotherapy alone, and the second part involves radiation therapy, with or without additional chemotherapy, depending on the cancer's location and stage.

Description

The treatment in this study has two parts. The first part is called induction chemotherapy and lasts 6-9 weeks, depending on your group. The second part is radiation therapy, which may include chemotherapy, depending on your cancer's location and stage.

Study Drugs:

  • Paclitaxel, Carboplatin, and 5-Fluorouracil: These drugs aim to stop cancer cells from dividing, which may lead to their death.
  • Docetaxel: This drug is designed to stop cancer cell growth and may damage blood vessels in tumor tissue.
  • Cisplatin: Contains platinum to poison cancer cells, potentially causing them to die.
  • Cetuximab: Works by blocking proteins inside cancer cells, slowing or stopping their growth.

Study Groups:

  • Group A: Receives cetuximab, paclitaxel, and carboplatin.
  • Group B: Receives cetuximab, docetaxel, cisplatin, and 5-fluorouracil.

Part 1: Induction Therapy

  • Group A: Weekly infusions of cetuximab, paclitaxel, and carboplatin for 6 weeks.
  • Group B: Infusions of cetuximab, docetaxel, and cisplatin, plus a continuous 4-day infusion of 5-fluorouracil every 21 days, for 3 cycles.

Part 2: Radiation Therapy

  • Begins 2-4 weeks after induction therapy.
  • May include chemotherapy with carboplatin or cisplatin.
  • Radiation is given Monday through Friday for about 7 weeks.

Follow-Up:

  • Physical exams, blood tests, and imaging scans to monitor the cancer.
  • Regular check-ups every 3 months for 2 years, then as needed.

Length of Study:

  • Treatment lasts about 15-16 weeks. If the cancer worsens or side effects are intolerable, treatment will stop.

This study is investigational, meaning the combination of these drugs for this type of cancer is still being researched. Up to 128 patients will participate, with up to 100 at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
  • Biopsy available to determine HPV status.
  • Stage IV disease, with specific tumor and lymph node involvement.
  • ECOG performance status of 0 or 1, indicating good overall health.
  • Age 18 or older.
  • Adequate blood cell counts and organ function.
  • Creatinine clearance of 40 ml/min or higher.
  • No serious health conditions that would affect chemotherapy.
  • Willing to sign informed consent.

Exclusion Criteria

  • Cancer type other than squamous cell carcinoma.
  • Cancer has spread beyond the head and neck.
  • ECOG performance status greater than 1.
  • Previous chemotherapy within the last 3 years.
  • Previous radiation to the head and neck.
  • Previous treatment with cetuximab or similar drugs.
  • Initial surgery that removed all visible cancer.
  • Other active invasive cancers.
  • History of another cancer, unless treated and disease-free for over 3 years.
  • Men and women of childbearing potential not using effective contraception.
  • Pregnant or breastfeeding women.
  • Pre-existing severe nerve damage.
  • Hemoglobin level below 8.0 g/dL.
  • Severe allergic reaction to docetaxel or similar drugs.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute20115BostonMassachusetts
University of Texas MD Anderson Cancer Center77030HoustonTexas

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