Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer

Official Title

Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC

Summary:

This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumour cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumour cells and shrink tumours. Metformin hydrochloride may shrink tumours and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.

Trial Description

Primary Outcome:

  • PFS
Secondary Outcome:
  • OS
  • Rate of treatment-related adverse events using National Cancer Institution (NCI) CTCAE, v. 4
  • Time to DM
  • Time to LRP
PRIMARY OBJECTIVES:
I. To determine whether metformin hydrochloride (MET) added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES:
I. Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM). II. Evaluate the effect of MET on chemoradiotherapy toxicity (Common Terminology Criteria for Adverse Events, version 4 [CTCAE, v. 4]) within 1 year of completion of all treatment. III. Collect biospecimens to develop biomarkers of MET activity. OUTLINE:

Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and undergo radiation therapy (3-dimensional conformal radiation therapy [3D-CRT] or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy comprising paclitaxel IV and carboplatin IV on days 1 and 22. Treatment with consolidation chemotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) or thrice daily (TID) for 14 days. Beginning on day 15, patients undergo radiation therapy and receive paclitaxel and carboplatin as in Arm I, and receive metformin hydrochloride BID or TID for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy as in Arm I and metformin hydrochloride PO BID or TID for 10 weeks. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society