Inhibition of CArbonic Anhydrase in Combination With Platinum and Etoposide-based Radiochemotherapy in Patients With Localized Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy in localized small cell lung cancer due to:

1. The over-expression of carbonic anhydrases in this type of cancer,

2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines,

3. The observed synergy between irradiation and inhibition of carbonic anhydrases,

4. Potential anti-tumor immune effect caused by decreased extracellular acidity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Antoine Lacassagne
• Treatments: Acetazolamide; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• Age > or = 18 years,

• Performance Status 0 to 2,

• Patient with an histologically non-metastatic localized Small cell lung cancer,

• Patient who must start radiotherapy treatment combined with chemotherapy with platinum and etoposide, Note: The decision of the Multidisciplinary Consultation Team must be notified in the patient's medical file,

• Evaluation lesion according to the criteria RECIST 1.1 and / or according to the criteria PERCIST 1.0,

• Women of childbearing potential must have a negative serum pregnancy test within 72 hours of the first administration of the study treatment,

• If the patient is a woman of childbearing potential, she must be surgically sterile or agree to use two adequate methods of contraception throughout the duration of the study until 1 month after the last administration of the study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,

• If the male patient has one or more female partners of childbearing age, he / she must agree to use an adequate method of contraception, starting at the first administration of the study treatment up to 1 month after the last administration of the treatment. of the study, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,

• Patient willing and able to provide written informed consent/assent for the trial,

• Patient affiliated with a health insurance system.

Exclusion Criteria:

• Patient with metastatic disease,

• History of thoracic irradiation or near / in the thoracic irradiation field,

• Patient who refuses to participate in the study or unable to agree,

• Contraindication to thoracic radiotherapy treatment: congestive heart failure unbalanced (ejection fraction <30%, clinical signs), severe respiratory failure:

• COPD grade IV according to the GOLD classification,

• Some GOLD III COPD and any patient with a respiratory defect defined as: oxygen dependence and / or FEV1 <40% normal and / or, DLCO <40% predictive value and / or vital capacity <40% predictive value,

• Contraindication to acetazolamide: hypersensitivity to acetazolamide, severe hepatic, renal or adrenal insufficiency, sulfonamide intolerance, history of renal colic, allergy to wheat other than celiac disease,

• Patient currently receiving one or more treatments described in section 6.9 of the protocol,

• History of cancer, with the exception of cancers in complete remission for more than 5 years, completely resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer,

• People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women