Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: weekly paclitaxel with fixed dose of oral cyclophosphamide: weekly paclitaxel with fixed dose of oral cyclophosphamide as metronomic chemotherapy
Chemotherapy regimen :
1. Paclitaxel
Sponsors
JIPMER PONDICHERRY
Eligibility
Inclusion criteria
Inclusion criteria: 1 Confirmed histological diagnosis of gastric carcinoma. 2 Age 18 years to 70 years at time of enrollment 3 Recurrent and refractory gastric carcinoma 4 ECOG performance status 0 to 2 5 Documented disease progression as evidenced by clinical, radiological or both 6 Normal echocardiogram 7 Negative serum pregnancy test in women of child bearing age
Exclusion criteria
Exclusion criteria: 1 Active bleeding 2 History of severe hypersensitivity reaction to paclitaxel. 3 Patients having > grade 2 neuropathy 4 Patient planned for immunotherapy and anti-her-2 therapies. 5 Gastric outlet obstruction(GOO) without appropriate feeding procedure. 6 Biological parameters 1. Absolute granulocytes 2. Platelets 3. Hemoglobin 4. Serum albumin level 5. Bilirubin > 1.5 and AST/ALT >= 3 ULN or >= 5 ULN in case of liver metastasis 6. Sr. Creatinine > 2.0 or creatinine clearance of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MEDIAN PROGRESSION FREE SURVIVALTimepoint: AT THE END OF THE STUDY | — |
Secondary
| Measure | Time frame |
|---|---|
| CHANGES IN BIOMARKERSTimepoint: EVERY 3 MONTHLY AND ON PROGRESSION;Frequency of Drug toxicity graded as per CTCAE v5.0 grading.Timepoint: BEFORE EACH CHEMOTHERAPY CYCLE;OVERALL SURVIVALTimepoint: AT THE END OF THE STUDY;QUALITY OF LIFETimepoint: AT THE END OF THE STUDY;RESPONSE RATESTimepoint: AT THE END OF THE STUDY | — |
Countries
India
Contacts
Public ContactDr Shreyans Pinalkumar Patel
JIPMER, PONDICHERY
Outcome results
None listed