Capecitabine with cyclophophamide as maintenance therapy in advanced colorectal cancer patients
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2022/01/039157
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients must have histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease or locally unresectable disease.
-Histological diagnosis of the primary should have yielded adenocarcinoma
-If patient has undergone curative intent resection of the primary and had recurrence, recurrence should have occurred at least 1 year post completion of prior curative intent therapy
-Patient should have completed at least 4 months of standard of care chemotherapy with or without targeted therapy and achieved at least stable disease on response assessment post4monthsoftherapy. Achievement of stable disease partial response or complete response post 4 months of therapy can be considered for trial.
-Patient has no residual grade 2 or more toxicities at the time of recruitment due to the effects of prior therapy.
-ECOG performance status less than or equal 2
-Participants must have normal organ and marrow function as defined Hemoglobin more or equal 8gm%
-Women of childbearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control; abstinence) prior to 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 hertreatingphysicianimmediately.Mentreatedorenrolledonthisprotocolmustalsoagreeto use adequate contraception prior to the study for the duration of study participation and 6 months after completion of protocol.
- Ability to understand and the willingness to sign a written informed consent document
-Participants who are receiving any other investigational agents.
-Patients who are DPD enzyme mutant, homozygous variant
-Patients with history of repeated grade 3 HFS with prior 5-FU or Capecitabine based therapy
-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 capecitabine or cyclophosphamide
-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
Pregnant women and breastfeeding women are excluded from this study.
-HIV positive, Hepatitis B and C seropositive patients are excluded from th study
-Patients with previous history of other cancers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In phase I the OBD of capecitabine would be identified using response assessment criteria RECIST version 1.1 and flow cytometry measurement of CEC. So, a twin primary endpoints of clinical benefit rate at 2 months ( CR or PR or SD persisting till 2 months) and proportional decline in CEC will be used for determination of OBD. <br/ ><br> <br/ ><br>Timepoint: 30 months
- Secondary Outcome Measures
Name Time Method Toxicity would be assessed at clinical visits. Relation between biomarkers <br/ ><br>and disease control(clinical benefit rate and progression free survival) would be explored by using a suitable statistical test selected on the basis of type of data (continuous, ordinal) and its distribution.Timepoint: 30 months