Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: mFOLFOX plus Loxapine: Oxaliplatin 85 mg per m2 IV over 120 mins on Day 1
Leucovorin 200 mg per m2 IV over 2 hours on Day 1
5 FU 2400 mg/m2 IV over 46 hours of continuous infusion start
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients must have histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease or locally unresectable disease. 2.The patient must not have received prior chemotherapy for metastatic or advanced disease setting 3.Patients who progressed within 6 months of adjuvant chemotherapy will not be considered for the trial 4.MSS 5.Age Any patient aged above 18 years of either sex. There is no maximum age. 6.ECOG performance status 0 to 2. 7.Not affording targeted therapy drugs like Cetuximab. 8.Measurable lesion according to RECIST version 1.1 criteria on contrast enhanced CT scan of chest and abdomen and or pelvic region 9.Participants must have normal organ and marrow function as defined below: a.Hemoglobin more than equal to 8 b.Leukocytes more than equal to 3000 per mcL and Absolute neutrophil count more than equal to 1500 per mcL c.Platelets more than equal to 100,000 per mcL d.Total bilirubin less than 2 times into institutional upper limit of normal e.AST(SGOT) or ALT(SGPT) Less than 3 times into institutional upper limit of normal (Less than 5 times in case of liver metastases) f.Calculated Creatinine clearance more than 40 ml per min g.Albumin more than equal to 2.5 gm 10.Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 6 months after completion of the protocol. 11.Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Participants who are receiving any other investigational agents. 2.Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5 FU, Oxaliplatin, Acetazolamide, Dipyridamole and/or Loxapine. 3.History of adverse reactions to fluoropyrimidine drugs indicative of dihydropyrimidine dehydrogenase (DPD) deficiency or evidence of DPD deficiency on testing. 4.Patients with uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements. 5.Pregnant women and breastfeeding women or women with positive pregnancy test (women who have menstruated in the last year will be tested). 6.Active Hepatitis B or Hepatitis Cor evidence of HIV infection. 7.Patients with previous chemotherapy for other malignancies (excluding hormone therapy for breast cancer) 8.Other active malignancies (synchronous malignancies, and asynchronous malignancies separated by a 5-year disease-free interval)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) will be defined as the time from randomization to the time of disease progression, or lost to follow up, whichever is earlier.Timepoint: PFS to be analysed till disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate (RR) will be defined as the percentage of patients who have a partial response or Timepoint: complete response or stable disease to treatment at 2 months (i.e post 4 cycles).;Overall survival (OS) will be defined as the time from randomization to the time of death, lost to follow up or last observation, (whichever is earlier).Timepoint: the time from randomization to the time of death, lost to follow up or last observation, (whichever is earlier).;Duration of response (DOR) will be defined as the time from when a patient first responds {either a complete response (CR) or partial response (PR) as per RECIST 1.1} to a treatment until they either experience disease progression or die, whichever comes first.Timepoint: the time from when a patient first responds {either a complete response (CR) or partial response (PR) as per RECIST 1.1} to a treatment until they either experience disease progression or die, whichever comes first. | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed