Clinical trial · Interventional

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

Phase II Study of C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck

NCT00096174CI-TRIAL-00067671completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
cetuximab C225	Biological	—	UNRESOLVED
cisplatin	Drug	Cisplatin	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Cisplatin, C225, Radiation
description
* 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.
interventionNames
1. Biological: cetuximab C225
2. Drug: cisplatin
3. Radiation: radiation therapy

Primary outcomes (1)

measure
2-year Progression-free Survival Rate
timeFrame
assessed every 3 months for 2 years
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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:

      * Extension into the root of the tongue
      * Patient refuses total glossectomy
    * Tonsillar area, meeting 1 of the following criteria:

      * Extension into pterygoid area as manifested by x-ray or trismus
      * Extension across midline of pharyngeal wall
      * Direct extension into soft tissue of the neck
    * Unilateral neck node metastases fixed to carotid artery, mastoid, base of skull, or cervical spine with any of the above tumors
* Patients requiring total glossectomy are eligible
* Age\>=18 years
* ECOG Performance status of 0-1
* Adequate hematologic, renal, and hepatic function obtained \<=4 weeks prior to registration

  * Absolute neutrophil count ≥ 2,000/mm\^3
  * Platelet count ≥ 100,000/mm\^3
  * Hemoglobin ≥ 9.0 g/dL
  * Alkaline phosphatase ≤ 3 times normal
  * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3 times normal
  * Bilirubin ≤ 1.5 mg/dL
  * Creatinine ≤ 1.2 mg/dL OR creatinine clearance ≥ 50 mL/min
* Able to tolerate fluid load
* At least 14 days since major surgery (including dental extraction) except percutaneous endoscopic gastrostomy (PEG) placement or mediport placement

Exclusion Criteria:

* 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
* Clinically apparent jaundice
* Postoperative recurrence
* Other malignancy within the past 3 years except resected basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ tumors

References

Publications (1)

RESULTLanger 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.