Status:
COMPLETED
Altered Tumor Oxygenation by Metformin, a Potential Step in Overcoming Radiotherapy Resistance in LACC
Lead Sponsor:
Oslo University Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Poor tumor oxygenation (hypoxia) is an established negative prognostic and predictive factor in locally advanced cervical cancer (LACC). Hypoxia-modifying measures implemented in the clinic are lackin...
Eligibility Criteria
Inclusion
- Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma)
- Planned for radical chemoradiotherapy
- Over 18 years
- Speaks and understands Norwegian
- ECOG 0-1
- Cervical tumor available for biopsy by gynecological examination
- Hemoglobin ≥ 9 g/dL (blood transfusions are allowed)
- Leukocytes ≥ 3,5 x 10\^9/L 18
- Absolute neutrophil count ≥ 1,5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Total bilirubin ≤ 25 umol/L
- AST/ALT ≤ 2,5 x institutional upper limit
- Creatinine ≤ 90 or creatinine clearance ≥ 60 ml/min/1.73m2 Patients with elevated creatinine secondary to hydronephrosis may be eligible if renal function returns to normal after inserting an internal stent or nephrostomy
- Women of childbearing potential (WOCBP) should have a negative highly sensitive serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
Exclusion
- Evidence of distant metastasis. Suspicious paraaortic lymph nodes below the renal vessel are allowed if they are covered by the radiation field
- Patients who have received other cancer treatments for their cervical cancer
- Patients who receive other experimental drugs
- Known diabetes mellitus
- Currently taking Metformin or any other antidiabetic drugs (sulfonylureas, thiazolidinediones, insulin)
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to metformin
- Contraindications such as
- Hypersensitivity to the active substance or to any of the excipients listed Section 6.1.
- Severe renal failure (GFR \<30 ml / min).
- Acute conditions leading to the risk of renal impairment, eg: dehydration, severe infectious conditions, shock.
- Disease that can cause tissue hypoxia (especially acute illness or exacerbation of chronic illness), such as: acute decompensated heart failure, lung failure, recent heart attack, shock.
- Liver failure, acute alcohol intoxication, alcoholism.
- Any condition associated with increased risk of metformin- induced lactic acidosis (congestive heart failure defined as New York Heart Association (NYHA) class III or IV functional status, history of acidosis of any kind)
- Uncontrolled intercurrent somatic illness including, but not limited to, ongoing or active serious infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months and cerebrovascular disease with previous stroke
- Already on medication with increased risk of lactic acidosis
- Patients who are pregnant or breastfeeding are excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04275713
Start Date
May 22 2020
End Date
November 8 2024
Last Update
January 20 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0379