| CTRI Number |
CTRI/2009/091/000519 [Registered on: 17/12/2009] |
| Last Modified On: |
02/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
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Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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EGF105884: Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Head And Neck Cancer |
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Scientific Title of Study
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EGF105884 : A Randomized, Double-Blind, Placebo Controlled, Multicentre, Phase II Study of Oral Lapatinib in Combination With Concurrent Radiotherapy and Cisplatin Versus Radiotherapy and Cisplatin Alone, in Subjects With Stage III, IVA, B Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| EGF105884 |
Other |
| GM2005/00448/04 version 4 dated 29 August 2012 |
Protocol Number |
| NCT00387127 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Vrishali Desai |
| Designation |
Medical Director |
| Affiliation |
GlaxoSmithKline Pharmaceuticals Limited |
| Address |
GlaxoSmithKline Pharmaceuticals Limited
252, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400 030
India |
| Phone |
912224959581 |
| Fax |
912224946339 |
| Email |
vrishali.r.desai@gsk.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Dr Siddhi Dalvi |
| Designation |
Senior CRA |
| Affiliation |
GlaxoSmithKline Pharmaceuticals Limited |
| Address |
GlaxoSmithKline Pharmaceuticals Limited
252, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400 030
India |
| Phone |
912224959393 |
| Fax |
912224947415 |
| Email |
siddhi.s.dalvi@gsk.com |
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Source of Monetary or Material Support
Modification(s)
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| GlaxoSmithKline Pharmaceuticals Limited.
Dr. Annie Besant Road, Worli, Mumbai 400030 |
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Primary Sponsor
Modification(s)
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| Name |
GlaxoSmithKline Pharmaceuticals Limited |
| Address |
Dr. Annie Besant Road, Worli, Mumbai 400030 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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Countries of Recruitment
Modification(s)
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India
Canada
France
Hungary
Netherlands
Peru
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rejnish Kumar |
Regional Cancer Centre |
7th floor, Medical college campus,
PO box no 2417
Trivandrum 695011
Thiruvananthapuram
KERALA |
914712443814
rejnish@yahoo.com |
| Dr. Sarbani Laskar |
Tata Memorial Hospital |
Dr. E. Borges Road,Parel-400012
Mumbai
MAHARASHTRA |
022 24177000
sarbanilaskar@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, RCC |
Approved |
| Human Ethics Committee, TMC |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Squamous Cell Carcinoma of the Head & Neck, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Lapatinib |
Lapatinib (1500 mg daily) plus chemoradiotherapy (cisplatin - 100mg/m2 and 60 - 70 Gy radiation) |
| Comparator Agent |
Placebo |
Placebo plus chemoradiotherapy (cisplatin - 100mg/m2 and 60 - 70 Gy radiation) |
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Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1)Willing and able to sign a written informed consent;
2)Histologically confirmed diagnosis of SCCHN of one or more of the following sites: oral cavity, oropharynx, hypopharynx and larynx;
Multiple primary tumours will:
•Have to be histologically proven;
•Have to be anatomically distant and surrounded by normal tissue;
3) Subjects with stage III and IVA/IVB disease, who are to receive cisplatin chemotherapy and radiation therapy as primary treatment (total dose 65 Gy (IMRT) or 70 Gy (2D or 3D RT));
•Subjects T1N1 or T2N1 disease are excluded.
•Subjects with distant metastases, ie Stage IVC, are excluded.
4)Willing and able to have a tumour biopsy taken at screening; For patients who have had prior tumour biopsy, an adequate archived specimen must be available.
5)Male or female 18 years of age and above;
Criteria for female subjects or female partners of male subjects: Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are post- menopausal);
Child-bearing potential (i.e. women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhoea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:
A)Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or
B)Consistent and correct use of one of the acceptable methods of birth control:
6)ECOG performance status 0, 1 or 2;
7)Subjects must have adequate haematological, renal and hepatic function;
(a)Calculated creatinine clearance more than or equal to 60 ml/min
(b)Absolute neutrophil count more than or equal to 1,500/µl, platelets more than or equal to 100,000/µl.
(c)Haemoglobin more than or equal to 9g/dL (5mmol/L).
(d)Aspartate (AST) and alanine transaminase (ALT) less than 3 times the upper limit of the normal range (ULN).
(e)Total bilirubin more than or equal to 2.0 mg/dL.
8)Left ventricular ejection fraction (LVEF) within the institutional normal ranges as measured by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan;
9)Able to swallow tablets whole or swallow a suspension of tablets dissolved in water at study inclusion;
The use and timing of feeding tube is optional. If necessary, the suspension may be administered via percutaneous endoscopic gastrostomy (PEG), percutaneous jejunostomy tube (J- Tube), or a nasogastric tube (NG or Dobhoff type tube).
10)Life expectancy of at least 6 months in the best judgment of the investigator.
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| ExclusionCriteria |
| Details |
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1) Nasopharyngeal, paranasal sinuses or nasal cavity tumours;
2) Any prior or current treatment for invasive head and neck cancer of any kind. This will include but is not limited to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior surgical resection, or use of any investigational agent;
3) Concurrent use of CYP3A4 inducers or inhibitors. A standard 3 to 5-day course of dexamethasone for the prevention of cisplatin-induced nausea and vomiting is permitted;
4) Serious cardiac illness or medical conditions including but not confined to:
•History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF less than Institutional LLN);
•High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled);
•Angina pectoris requiring antianginal medication;
•Clinically significant valvular heart disease;
•Evidence of transmural infarction on ECG;
5) History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma. History of non-invasive lesion or in-situ carcinoma that was successfully treated with surgery, photodynamics or laser, will be permitted;
6) Peripheral neuropathy greater than or equal to grade 2;
7) Pregnant or lactating females (female subjects of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
8) Other concurrent serious diseases that may interfere with planned treatment including malabsorption syndrome, disease significantly affecting GI function, that could affect absorption of lapatinib;
9) History of allergic reactions to appropriate antiemetics (e.g. 5-HT3 antagonists) to be administered with platinum chemotherapy;
10) The investigator considers the subject unfit for the study as a result of the medical interview, physical examinations, or screening investigations;
11) Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Complete response rate to treatment(as assessed by RECIST criteria) at six months after completion of chemoradiation treatment. |
six months after completion of chemoradiation treatment. |
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Secondary Outcome
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| Outcome |
TimePoints |
| Other intratumoural biomarker expression and relationship to disease control rate; Proteomic profile in peripheral blood; Analysis of DNA, RNA and determining HPV infection from tumour samples.
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| Progression-free survival at six months and one year overall survival disease-specific survival locoregional control distant relapse volumetric tumour response measurements adverse events intratumoral biomarker expression |
Six months & One Year |
| Disease-specific survival; Loco-regional control; Distant relapse; Volumetric tumour response measurements; Adverse events; Changes in serum ErbB1 ECD levels related to disease control rate |
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Target Sample Size
Modification(s)
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Total Sample Size="100"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
19/02/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
16/11/2006 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="9"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
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Publication currently not available |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.
12 patients have been recruited from India. Date of first enrollment in India is 19th February 2007. |