Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix

Korábbi kezelés

• Pts on any drugs which has pharmacological interaction with nelfinavir:
  • Terfenadine, cisapride, sildenafil, lovastatin or simvastatin and medication that are metabolized by the CYP3A4 isoenzyme.
  • Antiarrhythmics (amiodarone, quinidine).
  • Neuroleptics (pimozide).
  • Sedative/Hypnotic agents (midazolam, triazolam).
  • Ergot derivatives.
  • HMG-CoA reductase inhibitors (atorvastatin).
  • Rifampicin, Rifabutin.
  • Felodipine, Nifedipine.

Más betegség

• Active co existing malignancy.
• HIV positive patients will be excluded.
• History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Laborértékek

• Patients with newly diagnosed diabetes , uncontrolled DM (patient with HbA1c of \> 6.5% or FBS value or BSF\>=126 mg/dL respectively on primary evaluation)
• Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded.

Egyéb

• Pregnant or lactating
• Patients with hemophilia.

• ECOG 0 to 2
• FIGO 2018 Stage IIIA (TNM stage T3a N0 M0) FIGO 2018 Stage IIIB (TNM stage T3b N0 M0) FIGO 2018 Stage IIIC (TNM stage Any T N1 M0)
• No previous irradiation to the pelvis or chemotherapy
• Age 18 years and above
• Ability to tolerate full course of pelvic radiotherapy and brachytherapy
• Adequate bone marrow, liver, and kidney function defined as neutrophil count ≥ 1500 platelet count ≥ 100,000, total bilirubin less than 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN, and creatinine less than 1.5 upper limit of normal or Creatinine clearance greater than 60 mL/min/1.73 m2
• No recent (less than 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
• Ability to understand and the willingness to sign an informed consent document
• Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies