Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment [ Time Frame: up to 21 weeks ] [ Designated as safety issue: Yes ]
- Disease-free Survival at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).
Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study.
- Overall Survival at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)
|Study Start Date:||November 1999|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Radiation therapy plus concurrent weekly chemotherapy||Drug: cisplatin Drug: paclitaxel Radiation: brachytherapy Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003377
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees|
|Camden, New Jersey, United States, 08103|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Cleveland Clinic Cancer Center at Fairview Hospital|
|Cleveland, Ohio, United States, 44111|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210|
|Riverside Methodist Hospital Cancer Care|
|Columbus, Ohio, United States, 43214|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Joan L. Walker, MD||Oklahoma University Cancer Institute|