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

NCT00468169 | Completed Phase 2 Results DMC

• 1 other identifier: 14401A
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Cetuximab; Erbitux; locally; advanced; head; neck; cancer; neoplasms; squamous; carcinoma; lymphoepithelioma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  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.

  1 years

• Progression Free Survival (PFS)

  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.

  2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  2 years

• Objective Response Rate to Induction

  Post-Induction (8 weeks)

• Objective Response Rate to CRT

  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

• Residual Lymph Node Disease

  Up to 10 weeks

Study Arms (2)

A: Cetuximab+FHX

EXPERIMENTAL

Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.

Drug: Cetuximab; Drug: 5-FU; Drug: Hydroxyurea; Radiation: Twice-daily radiation

B: Cetuximab + PX

EXPERIMENTAL

Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.

Drug: Cetuximab; Drug: Cisplatin; Radiation: Accelerated fraction radiotherapy with concomitant boost

Interventions

Cetuximab DRUG

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

Also known as: Erbitux (R)

A: Cetuximab+FHX; B: Cetuximab + PX

5-FU DRUG

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

A: Cetuximab+FHX

Hydroxyurea DRUG

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

A: Cetuximab+FHX

Twice-daily radiation RADIATION

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

A: Cetuximab+FHX

Cisplatin DRUG

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

B: Cetuximab + PX

Accelerated fraction radiotherapy with concomitant boost RADIATION

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

B: Cetuximab + PX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Carcinoma

Interventions

Cetuximab; Fluorouracil; Hydroxyurea; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Urea; Amides; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Everett E Vokes, MD
• Organization: University of Chicago

evokes@medicine.bsd.uchicago.edu

(773) 702-9306

Study Officials

• Everett E Vokes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: July 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Locations

US (1)