Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase II, randomized study of placebo versus metformin in association to chemotherapy with capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: Capecitabine; Metformin

Criteria

Inclusion Criteria:

• 18 years or older;

• biopsy proven poorly differentiated carcinoma or adenocarcinoma of the rectum;

• lesions located within 12 cm of the anal verge (from colonoscopy assessment);

• ability to tolerate oral treatment;

• locally advanced tumor, classified by the presence of positive regional lymph nodes or primary tumor invasion beyond the serosa (T3 or T4), assessed by MRI;

• eligibility for curative surgery (no distant metastasis or invasion of bony structures of the pelvis);

• Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) 0-2;

• adequate hematologic functions (hemoglobin ≥ 10 g / dL [5.6 mmol / L]; neutrophil count ≥ 1,500 / mm3 and platelet count ≥ 100,000 / mm3), adequate renal function (serum creatinine less than 1.5 times the UNL) and adequate hepatic function (bilirubin less than 1.5 times the UNL; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the UNL);

Exclusion Criteria:

• known hypersensitivity to metformin or its excipients;

• squamous carcinomas of the rectum or anal canal;

• chronic treatment with corticosteroids or other immunosuppressive agents;

• treatment with oral antidiabetic products;

• distant metastasis at diagnosis or tumor invasion of pelvic bone structures that may proscribe curative intent surgery;

• chronic or acute infections;

• use of drugs under study up to four weeks prior to randomization;

• pregnant or nursing patients;

• prior radiotherapy to the pelvic region;

• myocardial infarction up to six months prior to randomization, or uncontrolled ischemic heart disease;

• congestive heart insufficiency New York Heart Association (NYHA) III-IV.