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 survivalTime 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 = 80 years of age.
2. Unresected and pathologically (histologic) proven Stage 3a or Stage 3b NSCLC of
adenocarcinoma, squamous cell, large cell or mixed histology, diagnosed within three
months of study randomization.
3. Non-metastatic disease staged by: physical examination, CT-chest and upper abdomen,
brain MRI or contrast-enhanced CT and whole body Fluorodeoxyglucose (FDG)-PET/CT scan
within two months of study randomization.
Exclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status >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
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