Metformin as Chemo-sensitizer in Ovarian Malignancies

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Histologically confirmed carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma

2)Patients to undergo fine needle aspirate (FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically directed biopsies showing adenocarcinoma

3)AND raised CA125 OR CA125 to CEA ratio more than 25 OR CA125 less than equal to 250 with no evidence of GI cancer;

4)They should have presumed stage III or IV disease, generally based on abdominal carcinomatosis, omental caking, pleural effusions or ascites

Exclusion Criteria

1)Patients who are receiving any other investigational agents.

2)Patients with comorbidities that would limit their survival.

3)Patients with known diabetes and already on metformin, sulfonylureas, thiazolidinediones or insulin for any reason.

4)Concurrent active malignancy or one previously diagnosed.

5)History of allergic reactions to similar drugs as used in the trial. New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages per day- as these conditions are associated with increased risk of metformin-associated lactic acidosis.

6)Uncontrolled intercurrent illness like- active major infection, or psychiatric illness/social situations, or unstable angina pectoris, that would limit compliance with study requirements.

7)Pregnant or nursing women.

8)Borderline tumors.

9)Patients who will undergo intraperitoneal chemotherapy.

10)Patients receiving chemotherapy regimens not specified in the inclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy Response Score (CRS) and its correlation with Clinico-radiological response with CECT using RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)Timepoint: Chemotherapy Response Score (CRS) and its correlation with Clinico-radiological response with CECT using RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) will be done at 4-6 weeks post completion of neo-adjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
a.) Incidence of Adverse Events graded according to NCI-CTCAE version 4.0 (National Cancer Institute- Common Terminology Criteria for Adverse Events), and b.) Median Disease Free Survival defined as the time from randomization to recurrence of tumor or death.Timepoint: 2.5 years