Health Condition 1: null- Metastatic Colon Cancer.
Conditions
Interventions
Intervention1: Oxaliplatin IV infusion: Oxaliplatin 85 mg/m2 IV infusion in 250-500 ml 5% Dextrose injection will be given over 120 minutes
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing to provide written informed consent and comply with study procedures. 2.Male or Female Subjects with greater than or equal to 18 yrs and less than or equal to 70 yrs. 3.Subjects with histologically or cytologically proven metastatic colon cancer with atleast one measurable lesion. 4.Performance Status ECOG of 0-2. 5.Platelet count greater than or equal to 100,000/cu mm. 6.Adequate renal function (Creatinine less than 1.5 mg/dL). 7.Adequate liver function (Bilirubin less than 2.0 mg/dL, Transaminase levels less than 2.5 times the upper normal limit). 8.Life expectancy of atleast 12 months as per the investigators discretion.
Exclusion criteria
Exclusion criteria: 1.Subjects who have received chemotherapy for metastatic colon cancer within a period of 12 months prior to screening. 2.Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks prior to randomization. 3.Pregnant or lactating women or women of child bearing potential not using a contraceptive method. 4.A serious uncontrolled medical disorder that, in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy. 5.Known metastases in the central nervous system and grade three sensory neuropathy as per NCI CTC grading for neuropathy. 6.Subjects with interstitial lung disease or pulmonary fibrosis. 7.Evidence of any other serious illness or medical conditions. 8.Subjects with known allergy to Oxaliplatin or other platinum compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieve complete or partial response will be assessed for overall response as per RECIST Version 1.1 using imaging studies (MRI/CT) at Visit 7 (Day 85) and Visit 13 (Day 169)Timepoint: At Visit 7 (Day 85) and Visit 13 (Day 169) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of subjects with progression free survival, median time to progression free survival.Timepoint: At Visit 7 (Day 85) and Visit 13 (Day 169);2.Time to progression (TTP) defined as the time from the start of treatment to the date of documented progression will be assessed using MRI/CT at Visit 7 (Day 85) and Visit 13 (Day 169)Timepoint: At Visit 7 (Day 85) and Visit 13 (Day 169);3.Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s)Timepoint: During study period.;4.Treatment Emergent Adverse Events (TEAE defined as an AE which is definitely or probably related to study medication) as per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02.Timepoint: During study period. | — |
Countries
India
Contacts
Public ContactDr Ajay Mehta
Associate Director Medical Affairs & Safety
Outcome results
None listed