A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
- To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of
adjuvant carboplatin and paclitaxel chemotherapy following concurrent weekly cisplatin
chemotherapy and extended-field radiation in women with newly diagnosed Stage IB-IVA
cervical cancer, with positive para-aortic nodes.
- To determine the feasibility of the treatment regimen over the four courses of adjuvant
chemotherapy once the MTD is estimated.
- To assess the toxicities of the treatment regimen according to the NCI Common
Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
- To assess the response rate to this treatment regimen in patients with measurable
- To examine progression-free survival at one year on this treatment regimen.
- To examine overall survival.
- To estimate the frequency of chronic toxicities experienced within one year of study
OUTLINE: This is a multicenter, dose-escalation study of carboplatin and paclitaxel.
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 and undergo extended-field
radiotherapy (including brachytherapy) once daily, 5 days a week, for 6 weeks.
Beginning 4-6 weeks after completion of chemoradiation, patients receive adjuvant
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on
day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 1 year.
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) of adjuvant carboplatin and paclitaxel
Cecelia H. Boardman, MD
Massey Cancer Center
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|