CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Cetuximab +4 morebiological
Likely dose
Cetuximab 400 mg/m² IV loading dose, then 250 mg/m² weekly for weeks 2-6; carboplatin AUC 2 weekly for 6 courses; paclitaxel 135 mg/m² weekly for 6 coursesAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed squamous cell carcinoma from oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
  • ✓Stage IV disease (T0-4 N2b/2c/3 M0, or N1 for nasopharynx) with measurable disease by RECIST
  • ✓Karnofsky performance status ≥80 or ECOG 0-1
  • ✓Age >16 years
Key exclusion· 9
  • ✕Non-squamous cell carcinoma histology
  • ✕Distant metastases below the clavicle
  • ✕Prior chemotherapy within 3 years
  • ✕Prior radiotherapy to head and neck

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00301028
NCT00301028Phase 2Completed
CompareCT.gov

Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma

M.D. Anderson Cancer Center·interventional·Posted Mar 10, 2006·Updated Apr 5, 2013

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Carboplatin, and 3 other interventions for Head and Neck Cancer. Completed, enrolled 48 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy, with or without cisplatin, may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating patients with metastatic head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2006
Enrollment StartApr 1, 2006
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.3 years ago

Interventions

Cetuximabbiological

Beginning weekly dose 400 mg/m\^2 IV over 1-2 hours, and 250 mg/m\^2 weeks 2-6.

Carboplatindrug

AUC 2 weekly for 6 courses.

Paclitaxeldrug

135 mg/m\^2 weekly for 6 courses.

Conventional Surgeryprocedure

Following induction in second part of study.

Radiation Therapyradiation

Following induction in second part of study.