drugset / Trial / NCT01554410

Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma

NCT01554410 ↗

Phase 1 Completed 35 enrolled University of California, San Diego
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.

Timeline

Start
2010-08
Primary completion
2019-07-16
Completion
2020-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Gemcitabine Small molecule 50 mg/m2 Intravenous
Subject Gemcitabine Small molecule 75 mg/m2 Intravenous
Subject Gemcitabine Small molecule 100 mg/m2 Intravenous
Subject Gemcitabine Small molecule 125 mg/m2 Intravenous

Indications