Status:
ACTIVE_NOT_RECRUITING
Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Carcinoma Cervix,Stage III
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief 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 Radioth...
Detailed Description
The trial is a single centre open label randomized unblinded phase-III study to evaluate the efficacy of an investigational drug (Nelfinavir) in combination with standard therapy consisting of weekly ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT03256916
Start Date
January 16 2018
End Date
January 30 2026
Last Update
January 2 2026
Active Locations (1)
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1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012