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
OBJECTIVES:
- 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.
Interventional
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
Yes
Joan L. Walker, MD
Study Chair
Oklahoma University Cancer Institute
United States: Federal Government
CDR0000066371
NCT00003377
November 1999
July 2009
Name | Location |
---|---|
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 |