Role of Nelfinavir during chemoradiation for Cervical Cancer
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2017/08/009265
- Lead Sponsor
- Tata Memorial Centre and Varian International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 < 1.5 x upper limit of normal (ULN), AST and ALT � 2.5 x ULN, and creatinine < 1.5 upper limit of normal OR Creatinine clearance > 60 mL/min/1.73 m2
6.No recent ( < 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �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 Outcome Measures
Name Time Method locoregional control and overall survival <br/ ><br> <br/ ><br>Other endpoints as listedTimepoint: Overall survival at 5 years