A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00409565|
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : July 12, 2016
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Squamous Cell Carcinoma||Drug: Cetuximab Drug: Bevacizumab||Phase 2|
Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States 1. Squamous cell carcinomas account for more than 90% of head and neck cancer cases. Patients with squamous cell carcinoma of the head and neck (HNSCC) usually present with locoregionally advanced disease. Initial presentation with distant metastasis may occur in about 10% of all patients. However, recurrence of disease either in local or distant sites after potentially curative treatment with surgery, radiation, and/or chemotherapy occurs in more than 50% of patients. Therefore, the majority of patients with HNSCC develop recurrent or metastatic disease during the course of their illness. These patients have a dismal prognosis with a median survival of 6-9 months 2-4.
Active single agents in head and neck squamous cell carcinoma include methotrexate, bleomycin, cisplatin, carboplatin, 5-FU, paclitaxel, docetaxel, and CPT-11. A small randomized study showed that cisplatin monotherapy prolongs survival compared with best supportive care 5. Response rates for single agents range between 10-40% 2, 4, 6, 7. Combination chemotherapy with platinum agents, in spite of achieving higher response rates (about 30% in phase III trials), has not been shown to produce a survival benefit compared to single agents in randomized comparisons in recurrent/metastatic head and neck cancer 2, 4.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: Cetuximab plus bevacizumab
Cetuximab plus bevacizumab
Other Name: Erbitux, C225Drug: Bevacizumab
Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given
Other Name: (rhuMAb VEGF, Avastin) (NSC 704865; IND 7921)
- Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (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; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]PFS is the length of time during and after treatment that patients are alive with the disease but it does not get worse. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI), Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]The length of time from the start of study/treatment that diagnosed patients are still alive.
- Change in Serum Cytokine Concentrations [ Time Frame: Up to 5 years ]Ratio of serum cytokines concentration after treatment with cetuximab and bevacizumab to baseline serum cytokines concentration, in picogram/milliliter (pg/ml) for 13 different cytokines. [post-treatment (pg/ml) / baseline (pg/ml)]
- Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR)) [ Time Frame: At 12 weeks ]
Disease Control Rate (DCR) (or Clinical Benefit Rate (CBR)), is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to cetuximab and bevacizumab.
DCR = number of patients with (at least) partial response or stable disease / total number of evaluable patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409565
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-0848|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|UPMC / UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|University of Texas MD Anderson|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Gibson, MD||Eastern Cooperative Oncology Group|