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.
Many studies have investigated multiagent chemotherapy as a means of intensifying treatment. The results of such trials indicate that gemcitabine has considerable activity against cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take advantage of the therapeutic benefits of gemcitabine IMRT is an advanced radiation therapy delivery technique that reduces the amount of radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer cells and other areas, such as lymph nodes. IMRT does this by using computers to design the best way to aim radiation at the tumor(s), while still delivering a radiation dose comparable to standard radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
45 Gy in 25 daily fractions (1.8 Gy per fraction)
Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)
Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)
Moores UC San Diego Cancer Center
La Jolla, California, United States
Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin
To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
Time frame: 5 weeks during treatment
Number of Participants with Acute Adverse Events as a Measure of Safety and Tolerability
To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.
Time frame: Up to 30 Days post-treatment
Number of Participants with Progression-Free Survival as a Measure of Response
To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
Time frame: Up to 12 months post treatment
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