A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine Cervix.

TMH Project 1543

The primary aim of the trial is to study the impact of nelfinavir on 3 year disease free survival in patients with advanced carcinoma of cervix receiving standard chemoradiation (Cisplatin and Radiotherapy). There will be two study groups. One group will receive standard treatment (concurrent chemoradiation and brachytherapy) \& other group will receive nelfinavir 5-7 days prior to standard treatment (chemoradiation \& brachytherapy).

2018-01-16

2025-09-30

2025-09-30

Recruiting

Early phase I

348

Inclusion Criteria * 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 Exclusion criteria * 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) * 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. * Pregnant or lactating * Active co existing malignancy. * HIV positive patients will be excluded. * Patients with hemophilia. * Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded. * History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two study arms. If patient is randomized to standard arm patient will receive concurrent chemoradiation and brachytherapy. If patient is randomized to nelfinavir arm then nelfinavir will be started at the dose of 1250 mg bid 5-7 days prior to standard treatment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 348, 'type': 'ESTIMATED'}}

2024-04-11