To study how safe and effective is Irinotecanin treatment of colorectal cancer patients.

Phase 4

Completed

Conditions: Metastatic colorectal cancer patients

Registration Number: CTRI/2011/05/001723

Lead Sponsor: Cipla Ltd

Brief Summary: 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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (4): Bibi General Hospital & Cancer Center
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Government Medical College
🇮🇳
Nagpur, MAHARASHTRA, India
Jeevandeep Oncosurgical Hospital
🇮🇳
Surat, GUJARAT, India
Seth Nandlal Dhoot Hospital
🇮🇳
Aurangabad, MAHARASHTRA, India
Bibi General Hospital & Cancer Center
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Mallik S
Principal investigator
09866008946
drmallik_s@rediffmail.com