Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Nelfinavir Arm: If patient is randomized to nelfinavir arm then nelfinavir will be started at the dose of 1250 mg bid 5-7 days prior standard treatment which consist of concurrent chemo
Sponsors
Tata Memorial Centre and Varian International
Eligibility
Inclusion criteria
Inclusion criteria: 1.ECOG 0-2. 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) 3.No previous irradiation to the pelvis or chemo therapy 4.Ability to tolerate full course of pelvic radiotherapy and brachytherapy 5.Adequate bone marrow, liver, and kidney function defined as neutrophil count � 1500, platelet count � 100,000, total bilirubin 60 mL/min/1.73 m2 6.No recent ( 7.Ability to understand and the willingness to sign an informed consent document. 8.Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies.
Exclusion criteria
Exclusion criteria: 1.Patients with newly diagnosed diabetes. uncontrolled DM that is patients with Hb1c of greater than 6.5% of FBS value or BFS greater than or equal to 126mg/dL respectively on primary evaluation 2.Patients 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. 3.Pregnant or lactating 4.Active co existing malignancy. 5.HIV positive patients will be excluded. 6.Patients with hemophilia. 7.Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded. 8.History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Improvement in disease free survival at 3 years, by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy).Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| locoregional control and overall survival Other endpoints as listedTimepoint: Overall survival at 5 years | — |
Countries
India
Contacts
Public ContactDr Supriya Jayant Sastri nee Chopra
Tata Memorial Centre
Outcome results
None listed