Overview

Combination of Metformin With Gefitinib to Treat NSCLC

Status:
Completed
Trial end date:
2018-06-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether metformin in combination with gefitinib are effective in patients with previously untreated advanced or metastatic Non-Small-Cell Lung cancer with epidermal growth factor receptor (EGFR) mutations
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Treatments:
Gefitinib
Metformin
Criteria
Inclusion Criteria:

- Patients must have Histologically or cytologically confirmed non small cell carcinoma
of the lung who harbors EGFR-mutation and are previously untreated

- Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent
disease) (according to the 7th edition of the tumor node metastasis (TNM)
classification system). However, patients with T4NX disease (stage III B) with
nodule(s) in ipsilateral lung lobe are not eligible, because such patients were not
included in historical controls.

- Patients be age >18 years and < 75 years.

- Patients must have a Life Expectancy of greater than 12 weeks.

- Patients must have an electrocorticography (ECOG) performance status 0 or 1 (Karnofsky
> 70%).

- Patients must have normal organ and marrow function as defined below, within one week
prior to randomization:

absolute neutrophil count >1,500/mL platelets > 100,000/mL total bilirubin: within normal
institutional limits AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
creatinine ≤ 1.5 X institutional upper limit of normal urine dipstick for proteinuria of <
less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <
500 mg of protein in 24 hours to allow participation in the study.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.

- Patients must have an international normalized ratio (INR) < 1.5 and a partial
thromboplastin time (PTT) no greater than upper limits of normal within 1 week prior
to randomization.

- Patients with a history of hypertension must be well-controlled (<150 systolic/<100
diastolic) on a stable regimen of anti-hypertensive therapy.

- Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situation that would limit
compliance with study requirements.

- Patients receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal
anti-inflammatory agents known to inhibit platelet function. Treatment with
dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or
cilostazol (Pletal)is also not allowed.

- Patients receiving therapeutic anticoagulation. Prophylactic anticoagulation of venous
access devices is allowed provided Section 3.10 is met. Caution should be taken on
treating patients with low dose heparin or low molecular weight heparin for DVT
prophylaxis during treatment with bevacizumab as there may be an increased risk of
bleeding.

- Prior use of chemotherapy.

- Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks
prior to entering the study. Note: Those who have not recovered from adverse events
due to these agents administered will be considered ineligible.

- Patients receiving any other investigational agents.

- Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must
have stable neurologic status following local therapy (surgery or radiation) for at
least 2 weeks, and must be without neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events.

- Patients with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to metformin and paclitaxel or other agents used in
the study are excluded.

- Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this
study because the agents used in this study may be teratogenic to a fetus. Because
there is an unknown but potential risk for adverse events in nursing infants secondary
to treatment of the mother with paclitaxel, breastfeeding women are also excluded from
this study.

- Patients that are HIV-positive on combination antiretroviral therapy due to the
potential for lethal infections when treated with marrow-suppressive therapy.