A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck (CHANGE)
This study has been completed.
Sponsor:
Merck KGaA
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01177956
First received: June 2, 2010
Last updated: July 3, 2012
Last verified: July 2012
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Purpose
The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in Asian subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma of the Head and Neck |
Biological: Cetuximab Drug: Cisplatin Drug: 5-Fluorouracil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects |
Resource links provided by NLM:
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Best Overall Response (BOR) [ Time Frame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011 ] [ Designated as safety issue: No ]BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.
Secondary Outcome Measures:
- Overall Survival (OS) Time [ Time Frame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011 ] [ Designated as safety issue: No ]Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
- Progression-free Survival (PFS) Time [ Time Frame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011 ] [ Designated as safety issue: No ]Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.
- Time to Progression (TTP) [ Time Frame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011 ] [ Designated as safety issue: No ]Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.
- Duration of Response [ Time Frame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011 ] [ Designated as safety issue: No ]Time from first assessment of Complete Response (CR) or Partial Response (PR) to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
| Enrollment: | 73 |
| Study Start Date: | December 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cetuximab + Cisplatin + 5-Fluorouracil (5-FU) |
Biological: Cetuximab
The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes. Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab. Other Name: Erbitux®
Drug: Cisplatin
Subjects will receive 75 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.
Drug: 5-Fluorouracil
Subjects will receive 750 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed written informed consent
- Inpatient
- Greater than or equal to (>=) 18 years of age
- Histologically or cytologically confirmed diagnosis of SCCHN
- Recurrent and/or metastatic SCCHN not suitable for local therapy
- Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified World Health Organization (WHO) criteria
- Karnofsky performance status (KPS) >= 80 percent at trial entry
- Neutrophils >= 1.5*10^9 per liter (L), platelet count >= 100*10^9 per L, and hemoglobin >= 90 gram per liter (g/L)
- Total bilirubin less than or equal to (<=)*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3*ULN
- Serum creatinine <=133 micromole per liter (mcmol/L)
- Serum calcium within normal range
- Effective contraception if procreative potential exists (applicable for both male and female subjects)
Exclusion Criteria:
- Prior systemic chemotherapy, except if given as part of a multimodal treatment which was completed more than 6 months prior to trial entry
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- Nasopharyngeal carcinoma
- Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
- Uncontrolled hypertension defined as systolic blood pressure >=180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
- Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
- Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
- Other concomitant anticancer therapies
- Documented or symptomatic brain or leptomeningeal metastasis
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
- Known drug abuse (with the exception of alcohol abuse)
- Known hypersensitivity or allergic reaction against any of the components of the trial treatment
- Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- Previous or current other squamous cell carcinoma (SCC)
- Evidence of previous other malignancy within the last 5 years
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- Intake of any investigational medication within 30 days before trial entry
- Legal incapacity or limited legal capacity
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177956
Locations
| China | |
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | |
| Beijing, China | |
| Jilin Cancer Hospital | |
| Changchun, China | |
| The Xiangya 2nd Hospital of Central South University | |
| Changsha City, China | |
| Fuijan Provincial Tumor Hospital | |
| Fuijian, China | |
| Nanfang Hospital of Nanfang Medical University | |
| Guangzhou, China | |
| Sun Yat-Sen Univesity Cancer Center | |
| Guangzhou, China | |
| Zhejiang Provincial Tumor Hospital | |
| Hangzhou, China | |
| Jiangsu Cancer Hospital | |
| Jiangsu, Nanjing, China | |
| Tumor Hospital of Guangxi Zhuang Autonomous Region / The Tumor Affiliated Hospital of Guangxi Medical University | |
| Nanning City, China | |
| Fundan University Shanghai Cancer Center | |
| Shanghai, China | |
| Eye & ENT Hospital of Fundan University | |
| Shanghai, China | |
| Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology | |
| Wuhan City, China | |
| Xijing Hospital, the Fourth Military Medical University | |
| Xi'an, China | |
| Korea, Republic of | |
| Clinical Trial Center of Medical Research Institute, Pusan National University Hospital | |
| Busan, Korea, Republic of | |
Sponsors and Collaborators
Merck KGaA
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01177956 History of Changes |
| Other Study ID Numbers: | EMR62241_055 |
| Study First Received: | June 2, 2010 |
| Results First Received: | July 3, 2012 |
| Last Updated: | July 3, 2012 |
| Health Authority: | China: Ministry of Health China: Food and Drug Administration |
Keywords provided by Merck KGaA:
|
Recurrent and/or metastatic squamous cell carcinoma of the head and neck 1st-line Cetuximab Chemotherapy |
EMR 62241 -055 Merck KGaA Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Cetuximab Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013