A study to assess the efficacy of combined treatment of a natural plant product (Resveratrol) and small amounts of metallic copper in reducing toxicity in patients receiving chemotherapy for advanced stomach cancers.

Not Applicable

Conditions: Health Condition 1: null- Patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers at Tata Memorial Hospital

Recruitment & Eligibility

Inclusion Criteria

1.Male or female patients 18 years and

above.

2.Patients who have given written

informed consent

3.Patients with performance status of 0, 1 or 2

(ECOG scale)

4.Treatment naÃ¯ve inoperable stage 4

adenocarcinoma of the distal stomach in whom

the GE junction of the stomach is free of

disease.

5.Histologically proven gastric adenocarcinoma;

6.No prior chemotherapy

7. No prior radiotherapy and or surgery

8. Adequate hepatic, renal, and hematologic

function at baseline.

Exclusion Criteria

1.Uncontrolled medical comorbidities like

hypertensive, diabetes mellitus, HbsAg and

HIV positive, etc.

2.Presence of gastric outlet obstruction

3.Gastro-esophageal junction cancers

4.Significant neuropathy

5.Presence of brain or leptomeningeal

metastases

6.Patients taking alternative / complementary

treatments

Primary Outcome Measures

Name	Time	Method
To determine an effective dose-level of R-Cu that can reduce: 1) CT - induced toxicity; 2) degree of DNA damage and inflammation in PBMCs; 3) levels of circulating inflammatory cytokines (PGE2,TNF-alpha, INF-gamma IL-6, IL-1, CRP,IL-4,IL-10 and IL-11) and 4) levels of circulating chromatin in patients receiving chemotherapy for stage IV gastric cancer.Timepoint: 1) serum concentration of inflammatory cytokines on days 0, 5, 10, 15 and 20 <br/ ><br> <br/ ><br>2) levels of circulating chromatin on days 0, 5, 10, 15 and 20 <br/ ><br> <br/ ><br>3) degree of DNA damage and inflammation in PBMCs on days 0, 5, 10, 15 and 20 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To evaluate the steady-state PK parameters for resveratrol and copper on Day 7 in patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers at 4-dose levels of R-Cu.Timepoint: The steady-state PK parameters for resveratrol and copper will be performed on Day 7 <br/ ><br>The sampling time points will be as follows: <br/ ><br>Group 1 (subjects 1 and 4 of the 4-doses of R-Cu): 0hr, 0.5hr, 3hr, 7hr, 12hr <br/ ><br>Group 2 (subjects 2 and 5 of the 4-doses of R-Cu): 0hr,1hr, 4hr, 8hr and 12hr. <br/ ><br>Group 3 (subjects 3 of the 4-doses of R-Cu): 0hr,2hr, 5hr, 10hr and 12hr. <br/ ><br>