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Completed

NCT Number: NCT00468169

Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

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Key information

Conditions

Head and Neck Cancer Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Stage III and IV head and neck cancer
  • Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
  • No prior chemotherapy or radiotherapy
  • Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Normal organ and marrow function

Exclusion criteria

  • Unequivocal demonstration of metastatic disease
  • Known severe hypersensitivity to drugs used in the study
  • Treatment with a non-approved or investigational drug within 30 days before Day 1
  • Incomplete healing from previous surgery
  • Pregnancy or breast feeding
  • Uncontrolled intercurrent illness including
  • Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
  • Acute hepatitis or known HIV
  • Severe baseline neurologic deficits
  • Prior therapy which specifically and directly targets the EGFR pathway
  • Prior severe infusion reaction to a monoclonal antibody

Treatment and study plan

Cetuximab

Drug

250mg/m2(day 1, weekly x 10);

Other names: Erbitux (R)

5-FU

Drug

600 mg/m2/day; days 0-5 (120 h total) every other week x 5

Hydroxyurea

Drug

500 mg PO BID, days 0-5 every other week x 5

Twice-daily radiation

Radiation

150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)

Cisplatin

Drug

100 mg/m2, week 1 and 4 on day 1 (or 2)

Accelerated fraction radiotherapy with concomitant boost

Radiation

72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 1 years

    Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  2. Progression Free Survival (PFS)

    Time frame: 2 years

    Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2 years

    Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.

  2. Objective Response Rate to Induction

    Time frame: Post-Induction (8 weeks)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  3. Objective Response Rate to CRT

    Time frame: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks

    Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.

  4. Residual Lymph Node Disease

    Time frame: Up to 10 weeks

    Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer

Acronym: EPIC

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
May 2, 2007
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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