Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

NCT00096174 | Completed Phase 2 Results

• 3 other identifiers: CDR0000390923U10CA021115E3303
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.

Conditions

Head and Neck Cancer

Keywords

stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

• 2-year Progression-free Survival Rate

  Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.

  assessed every 3 months for 2 years

Secondary Outcomes (2)

• 2-year Overall Survival Rate

  assessed very 3 months for 2 years

• Overall Response Rate

  assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry

Study Arms (1)

Cisplatin, C225, Radiation

EXPERIMENTAL

* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.

Biological: cetuximab C225; Drug: cisplatin; Radiation: radiation therapy

Interventions

cetuximab C225 BIOLOGICAL

400 mg/m\^2 IV over 120 minutes on Day 1, 250 mg/m\^2 IV over 60 minutes on Day 8, then weekly

Also known as: Cetuximab, Erbitux

Cisplatin, C225, Radiation

cisplatin DRUG

75 mg/m\^2 IV over 30-60 minutes starting day 15 every 3 weeks \* 3 (Days 1, 22, and 43 of radiation therapy (RT))

Also known as: Platinol, Platinol-AQ, CDDP, DDP, DACP, Platinum, cis-Platinum

Cisplatin, C225, Radiation

radiation therapy RADIATION

RT 70 Gy / 35 starting Day 15, 200cGy / d \* 7 weeks (35 fractions)

Cisplatin, C225, Radiation

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland)
• Unresectable locally advanced or regional stage IV disease
• No evidence of distant metastases
• Must have demonstrable primary tumor site
• Measurable disease
• Unresectable disease
• Meets the following criteria for unresectable disease by tumor site:
• Hypopharynx, meeting 1 of the following criteria:
• Extension across the midline of the posterior pharyngeal wall
• Any evidence of fixation to the cervical spine
• Larynx
• Direct subglottic extension (\>3cm) into surrounding muscle or skin
• Oral cavity
• Lesion precluding functional reconstruction
• Base of tongue, meeting 1 of the following criteria:

You may not qualify if:

• Pregnant or nursing
• Fertile patients do not use effective contraception
• Patients who refuse surgery but whose tumors are technically resectable OR whose tumors are unresectable for medical reasons are not eligible
• Disease metastases below the clavicles or elsewhere (M1) or with a postoperative recurrence
• Prior excisional surgery of head and neck tumor
• Prior radiotherapy to the head and neck region
• Prior chemotherapy
• Prior drugs that target the epidermal growth factor receptor pathway
• Prior chimerized or murine monoclonal antibody
• Active systemic infection
• Known allergy to murine proteins
• Severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
• Myocardial infarction within the past 3 months
• Uncontrolled congestive heart failure
• Unstable or uncontrolled angina

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Langer CJ, Lee JW, Patel UA, et al.: Preliminary analysis of ECOG 3303: concurrent radiation (RT), cisplatin (DDP) and cetuximab (C) in unresectable, locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 26 (Suppl 15): A-6006, 2008.

  RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Cisplatin; Platinum; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; 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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Therapeutics

Results Point of Contact

• Title: Study Statistician
• Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office

617-632-3012

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: April 8, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2016
• Last Updated: June 29, 2023
• Results First Posted: March 25, 2011

Record last verified: 2023-06