Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Hospital
• Treatments: Cisplatin; Nelfinavir

Criteria

Inclusion Criteria

• ECOG 0 to 2

• FIGO Stage III B Carcinoma Cervix

• No previous irradiation to the pelvis or chemotherapy

• Age 18 - 65 years

• 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

• Diabetes Mellitus.

• 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.