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Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy

Information source: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Metformin plus Chemo-radiotherapy (Drug); Chemo-radiotherapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ontario Clinical Oncology Group (OCOG)

Official(s) and/or principal investigator(s):
Theodoros Tsakiridis, MD, Principal Investigator, Affiliation: Juravinski Cancer Centre, Hamilton, Ontario, Canada

Overall contact:
Kathryn Cline, BSc, CCRP, Email: clinek@mcmaster.ca

Summary

ALMERA is a randomized, phase II, open label study in patients with locally advanced non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent chemotherapy versus the same treatment plus concurrent Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that has the potential to improve cancer patient outcomes.

Clinical Details

Official title: A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression free survival

Secondary outcome:

Overall survival

Time to loco-regional progression

Distant progression-free survival

Toxicities

Detailed description: This is a randomized, phase II, open label study in patients with locally advanced NSCLC which will compare standard RT (60-63 Gy for 6 weeks) plus concurrent Cisplatin-based chemotherapy (CRT) (standard arm) vs the same CRT plus treatment with Metformin concurrent with CRT and continuing for a total of 12 months (experimental arm). Ninety-four eligible and consenting patients will be randomized to one of the two treatment arms. Patients randomized to the experimental arm will receive Metformin (2000 mg/day) for a period of 12 months. Patients will be continuously evaluated for toxicity, will be assessed weekly at clinic visits during concurrent CRT treatment and at follow up clinic visits at 3, 6, 9 and 12 months (from the date of randomization). Disease progression will be evaluated every 3 months for up to 12 months. All patients will be followed for up to 24 months (2 years) for survival. The primary objective of this study is to determine the effect of Metformin on the proportion of patients free of disease progression at 12 months after initiation of drug treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age >/=18 to 2. 2. More than 10% weight loss in the past 3 months. 3. Diabetic patient or anyone currently taking Metformin, insulin or other anti-hyperglycemic therapy. 4. Pulmonary Function Test (PFTs) (within the last 12 weeks) with Forced Expiratory Volume (FEV)1 < 1. 2 litres per second or less than 50% of predicted. 5. Complete Blood Count (CBC) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care). 6. Fasting blood sugar levels of >/= 7. 0 mmol per litre. 7. Prior systemic chemotherapy for lung cancer. 8. Prior radiotherapy that would overlap with the planned treatment area. 9. Prior invasive malignancy within the past 3 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity or cervix). 10. Known Acquired Immune Deficiency Syndrome (AIDS). 11. Patients with increased risk for lactic acidosis:

- severe congestive heart failure (NYHA: class III or IV),

- history of metabolic acidosis,

- alcoholic intake of > 3 drinks daily,

- severe liver disease,

- renal failure

12. Known hypersensitivity or allergy to Metformin. 13. Known pregnancy or lactating female patient. 14. Geographic inaccessibility for follow-up. 15. Inability to provide informed consent.

Locations and Contacts

Kathryn Cline, BSc, CCRP, Email: clinek@mcmaster.ca

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada; Recruiting
Naseer Ahmed, Principal Investigator

Juravinski Cancer Centre, Hamilton, Ontario, Canada; Recruiting
Theos Tsakiridis, Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada; Recruiting
Andrew Robinson, Principal Investigator

Grand River Regional Cancer Centre, Kitchener, Ontario, Canada; Recruiting
Elaine Bouttell, Principal Investigator

Walker Family Cancer Centre - Niagara Health System, St. Catharines, Ontario, Canada; Recruiting
Theos Tsakiridis
Theos Tsakiridis, Principal Investigator

Montreal General Hospital - McGill, Montreal, Quebec, Canada; Recruiting
Bassam Abdulkarim, Principal Investigator

Additional Information

Starting date: September 2014
Last updated: August 21, 2015

Page last updated: August 23, 2015

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