Nelfinavir's effect on cervical cancer treatment
A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine Cervix.
This study is testing if adding nelfinavir to standard treatment can help people with stage III cervical cancer live longer without the disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT03256916 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of nelfinavir on disease-free survival in patients with stage III cervical cancer undergoing standard chemoradiation. Participants will be randomly assigned to receive either standard treatment or nelfinavir prior to their standard therapy. The study will involve 348 patients at the Tata Memorial Centre in Mumbai, with careful monitoring of eligibility and treatment protocols. The trial is designed to assess whether nelfinavir can enhance the effectiveness of existing treatment regimens.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with FIGO 2018 stage III cervical cancer who can tolerate the full course of treatment.
Not a fit: Patients with previous pelvic irradiation or chemotherapy, or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve disease-free survival rates for patients with advanced cervical cancer.
How similar studies have performed: Other studies have explored the use of radiosensitizers in cancer treatment, but the specific combination of nelfinavir with chemoradiation in cervical cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Centre — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Dr. Supriya J Sastri, MD — Tata Memorial Centre
- Study coordinator: Dr. Supriya J Sastri, MD
- Email: supriyasastri@gmail.com
- Phone: 9930958309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.