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CTRI Number  CTRI/2011/05/001723 [Registered on: 09/05/2011] Trial Registered Prospectively
Last Modified On: 06/08/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To study how safe and effective is Irinotecanin treatment of colorectal cancer patients.  
Scientific Title of Study   A Multi-Centre, Prospective, Open Label Study on the Safety and Efficacy of Irinotecan in Combination Chemotherapy for Metastatic Colorectal Cancer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP/12/10  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Antaryami Maharana 
Designation  Medical Monitor 
Affiliation  Sristek Consulting Pvt. Ltd 
Address  DLF, Cyber City, Block No. 3, 8th Floor, Gachibowli, Hyderabad 500 019 Andhra Pradesh.

Hyderabad
ANDHRA PRADESH
500 019
India 
Phone  09985312894  
Fax  04066129566  
Email  antaryami.maharana@sristek.com  
 
Details of Contact Person
Public Query  
Name  Mr Rahul Namjoshi 
Designation  Project Manager 
Affiliation  Cipla Ltd 
Address  3rd Floor, Raj Plaza, LBS Marg, Vikhroli West, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400 083
India 
Phone  09820978403  
Fax  02225787855  
Email  rahul.namjoshi@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855  
 
Primary Sponsor  
Name  Cipla Ltd  
Address  Bellasis Road, Mumbai Central, Mumbai, Phone: (022) 23082891 Fax: (022)25787855.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mallik S  Bibi General Hospital & Cancer Center  Consultant Radiation Oncologist, Bibi General Hospital & Cancer Center, Near Govt. Printing Press, Malakpet, Hyderabad,500036
Hyderabad
ANDHRA PRADESH 		 09866008946
04024410792
drmallik_s@rediffmail.com 
Dr K M Kamble   Government Medical College  Professor & Head Radiation Therapy, Govt. Medical College, Medical Square, Nagpur-440003
Nagpur
MAHARASHTRA 		 9850246275

nileshdongre@rocketmail.com 
Dr Ghanshyam N Patel  Jeevandeep Oncosurgical Hospital  Jeevandeep Oncosurgical Hospital, Ayush Building, 302 - 3rd Floor, Near Param Doctor House, Laldarwaja- Station Road, Surat – 395004
Surat
GUJARAT 		 09376913131

gnonco@gmail.com 
Dr Chandra Sekhar Tamane  Seth Nandlal Dhoot Hospital  Medical Oncologist,Seth Nandlal Dhoot Hospital, A1, MIDC, Chikalthana, Jalna Road,415570
Aurangabad
MAHARASHTRA 		 09225316906
0240-2485831
chandratamane@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Clinicom Independant Ethics Committee for Seth Nandlal Dhoot Hospital  Approved 
Clinicom Independent Ethics Committee for Jeevandeep Oncosurgical Hospital, surat for Dr. Ghanshyam N. Patel  Approved 
Institutional Ethics Committee of Bibi General Hospital & Cancer Center  Approved 
Institutional Ethics Committee, Government Medical College & Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Metastatic colorectal cancer patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Irinotecan injection  • Irinotecan injection 180 mg/m2 IV over 90 min, on Day 1, Day 15, Day 29 of each cycle. Combination Drug: • Leucovorin 200 mg/m2 IV over 2 hrs, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day30 of each cycle. • 5-Fluoro Uracil bolus 400 mg/m2 IV bolus, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day 30 of each cycle. • 5-Fluoro Uracil infusion 600 mg/m2 IV over 22 hrs, on Day1, Day 2, Day 15, Day 16, Day29, and Day 30 of each cycle. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Note: There is no upper age limit

1. Subjects or LAR willing to sign an IEC/IRB approved informed consent form before performing any study specific procedures or tests.
2. Male and female subjects greater than 18 years of age
3. Histologically or cytologically documented adenocarcinoma of the colon or rectum and progressive measurable metastatic disease.
4. Subjects in whom a treatment regimen including irinotecan is clinically indicated.
5. Subjects who have not received any prior chemotherapy for advanced disease, if adjuvant chemotherapy was administered then should have completed the chemotherapy at least 6 months prior to screening visit.
6. Subjects with ‘Eastern Cooperative Oncology Group’ scale performance status of less than or equal to 2.
7. Adequate organ and bone marrow function as evidenced by:
a. Hemoglobin greater than or equal to 9.0 g/dL
b. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
c. Platelet count greater than or equal to 100 x 109/L
d. Serum creatinine less than or equal to 1.5 × upper limit of normal (ULN) or creatinine clearance greater than 50 mL/min.
e. Aspartate amino transferase (AST) less than or equal to 2.5 x ULN in subjects with no liver metastasis and less than or equal to 5.0 x ULN in subjects with liver metastasis.
f. Total bilirubin less than 1.5 x ULN.
8. Men and women of childbearing potential who consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter.
9. Subjects must be willing and able to comply with scheduled visits and procedures.
10. Life expectancy greater than 6 months as per the investigator’s discretion. 
 
ExclusionCriteria 
Details  1. No other prior or concurrent malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
2. Subjects who have a history of presence of brain metastasis, uncontrolled seizure disorder, spinal cord compression, leptomeningeal disease or carcinomatous meningitis.
3. Subjects who are planning or in need for a major surgical procedure or radiotherapy (RT) during the study.
4. Subjects who have a history of any of the following conditions within 6 months prior to screening:
a. Clinically significant myocardial infarction or severe/unstable angina pectoris.
b. New York Heart Association (NYHA) class III or IV congestive heart failure.
c. Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism.
5. Subjects with a risk factor to develop interstitial pulmonary disease.
6. Subjects with renal dysfunction and those who are on dialysis
7. Subjects who are on treatment with:
a. Hormonal therapy, radiation therapy, immunotherapy, biological therapy, and major surgery within 4 weeks before screening.
b. Herbal preparations or other alternative medicine within 2 weeks prior to screening visit or during the study.
8. Preexisting bleeding diatheses or coagulopathy or the need for full-dose anticoagulation.
9. Significant and uncontrolled hepatic dysfunction.
10. Co morbid condition that could confound outcome.
11. Clinically detectable ascites and pleural effusions.
12. Subjects who have a history of active chronic inflammatory bowel disease and/or bowel obstruction within the last 3 months.
13. Subjects who are pregnant or breast feeding.
14. Known history of hypersensitivity reactions to investigational drug.
15. Subjects administered any investigational product within 30 days prior to screening. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall Objective Response Rate (ORR) by RECIST criteria version 1.1   Measured at baseline, before initiation of 3rd cycle (Day85), at the end of 6th cycle (Day240) and if required at the end of the study (1 year) 
 
Secondary Outcome  
Outcome  TimePoints 
Time to Progression (TTP) by RECIST criteria version 1.1  Measured at baseline, before initiation of 3rd cycle (Day85), at the end of 6th cycle (Day240) and if required at the end of the study (1 year) 
Incidence of adverse events  During study period of 1 year.  
Incidence of drug related adverse events  During study period of 1 year.  
Clinically significant vital examination or lab investigations  During study period of 1 year. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/05/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published in any journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The study is to evaluate the safety and efficacy of Irinotecan in combination chemotherapy for the treatment of subjects with metastatic colorectal cancer. During study, in addition to the screening visit, there will be a minimum of 3 visits in each chemotherapy cycle. Each subject will receive treatment for a minimum of 4 chemotherapy cycles and would be continued on treatment, as per the discretion of the investigator, for upto 6 cycles (if tolerated) as per standard protocol. End of study visit will be performed not later than 1 year since commencement of treatment. Total 40 subjects will be enrolled in the study from 3 centers across India.

 
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