This phase I trial studies the side effects and best dose of gemcitabine hydrochloride when given together with intensity-modulated radiation therapy and cisplatin in treating patients with stage IB-IVA cervical cancer. Drugs used chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with intensity-modulated radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01554410.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of weekly gemcitabine (gemcitabine hydrochloride) that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer.
SECONDARY OBJECTIVES:
I. To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.
II. To estimate therapeutic results (i.e. therapeutic intent) of IMRT with concurrent cisplatin and gemcitabine in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.
OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride.
Patients undergo intensity-modulated radiation therapy (IMRT) daily for 25-28 fractions beginning on day 1. Patients also receive cisplatin intravenously (IV) and gemcitabine hydrochloride IV on days 1, 8, 15, 22, 29 (cohorts 1-4). Patients receive gemcitabine hydrochloride followed by cisplatin in cohort 5 (and 5 [-2] and 5 [-1] if necessary). Patients may also undergo brachytherapy for a total of 5 fractions after the completion of IMRT at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months.
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorLoren K. Mell