Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: modified FOLFIRI plus Arsenic trioxide: Irinotecan 180mg per m2 IV over 90 mins on Day 1
Leucovorin 300mg per m2 IV over 2 hours on Day 1
5 FU - 2400mg per m2 IV over 46 hours continuou
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -Patients must have histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease or locally unresectable disease with the following mandatory prior treatment history -The patient should have received prior FOLFOX or CAPOX based chemotherapy with or without targeted therapy, and should have progressed on the same or have had poor tolerance to the regimen leading to the cessation of CAPOX or FOLFOX -In patients having received FOLFOX or CAPOX in the adjuvant setting post resection, documented disease relapse should have occurred within 6 months of prior completion of FOLFOX or CAPOX. ECOG performance status less than equal to 1. -Fit to receive doublet chemotherapy FOLFIRI or Singlet Irinotecan Not affording targeted therapy in the second line Participants must have normal organ and marrow function -Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 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 -Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: -Participants who are receiving any other investigational agents. -Patients with QTc prolongation defined as QTc interval greater than 440 ms in males and 480 ms in females -History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5 FU, Irinotecan, or ATO -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 illnesssocial situations that would limit compliance with study psychiatric illness/social situations that would limit compliance with study requirements -Pregnant women and breastfeeding women are excluded from this study -HIVpositive uncontrolled Hepatitis B or Hepatitis C patients are excluded from this study -Patients with a previous history of other cancers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Quality of life side effects and adverse event profileTimepoint: 5 year | — |
Countries
India
Contacts
Public ContactSujay Srinivas
Tata Memorial Hospital
Outcome results
None listed