A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
- Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and
cisplatin chemotherapy (as radiation sensitization) in patients with previously
untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes.
- Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus
extended field radiotherapy in this patient population.
- Determine the effect of this treatment regimen on progression-free survival, overall
survival, and site of recurrence (local vs distant) in these patients.
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis
daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after
external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with
external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by
cisplatin IV on days 1, 8, 15, 22, 29, and 36.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or until the time of recurrence or death.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment
up to 21 weeks
Joan L. Walker, MD
Oklahoma University Cancer Institute
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Oklahoma University Medical Center||Oklahoma City, Oklahoma 73104|
|Cancer Care Associates - Midtown Tulsa||Tulsa, Oklahoma 74104|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Cleveland Clinic Cancer Center at Fairview Hospital||Cleveland, Ohio 44111|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees||Camden, New Jersey 08103|