Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and carboplatin (combination chemotherapy) after cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying cisplatin and radiation therapy followed by paclitaxel and carboplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.
Drug: carboplatin-Taxol regimen
Procedure: adjuvant therapy
Radiation: external beam radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum-tolerated dose (MTD) of adjuvant carboplatin and paclitaxel [ Designated as safety issue: Yes ]
- Dose-limiting toxicities (DLT) of adjuvant carboplatin and paclitaxel [ Designated as safety issue: Yes ]
- Toxicities as assessed by NCI CTCAE v. 4 [ Designated as safety issue: Yes ]
- Response rate in patients enrolled with measurable disease [ Designated as safety issue: No ]
- Progression-free survival at one year and overall survival [ Designated as safety issue: No ]
- Location of recurrence (loco-regional versus distant) [ Designated as safety issue: No ]
- Chronic toxicities experienced within one year of study entry [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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 disease.
- 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 entry.
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.
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242-1002|
|Contact: Cancer Information Service 800-237-1225|
|United States, Ohio|
|Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Peter G. Rose, MD 216-444-1712|
|Riverside Methodist Hospital Cancer Care||Recruiting|
|Columbus, Ohio, United States, 43214-3998|
|Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475|
|United States, Oklahoma|
|Oklahoma University Cancer Institute||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Robert S. Mannel, MD 405-271-8787|
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island||Recruiting|
|Providence, Rhode Island, United States, 02905|
|Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298-0037|
|Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939|
|Principal Investigator:||Cecelia H. Boardman, MD||Massey Cancer Center|