Health Condition 1: null- Metastatic colorectal cancer patients
Conditions
Interventions
Intervention1: 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,
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Objective Response Rate (ORR) by RECIST criteria version 1.1Timepoint: 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
| Measure | Time frame |
|---|---|
| Clinically significant vital examination or lab investigationsTimepoint: During study period of 1 year.;Incidence of adverse eventsTimepoint: During study period of 1 year.;Incidence of drug related adverse eventsTimepoint: During study period of 1 year.;Time to Progression (TTP) by RECIST criteria version 1.1Timepoint: 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) | — |
Countries
India
Contacts
Public ContactMr Rahul Namjoshi
Sristek Consulting Pvt. Ltd
Outcome results
None listed