Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
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. 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.
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Radiation: external beam radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
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 determined by dose-limiting toxicities assessed by NCI CTCAE v. 4 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Objective tumor response rate in patients enrolled with measurable disease [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Will be tabulated overall.
- Progression-free survival [ Time Frame: Time from study entry to time of progression or death, assessed at 1 year ] [ Designated as safety issue: No ]Will be summarized using Kaplan-Meier plots.
- Overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 1 year ] [ Designated as safety issue: No ]
- Location of recurrence (loco-regional versus distant) defined as newly evident disease for patients who have no evidence of disease at baseline or progressive disease for patients who have strictly non-measurable disease at baseline [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Chronic toxicities experienced classified using the CTCAE Version 4 [ Time Frame: Within 1 year of study entry ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
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.
Radiation: external beam radiation therapy
Other Name: EBRTRadiation: brachytherapy
Other Names:Drug: cisplatin
Other Names:Drug: paclitaxel
Other Names:Drug: carboplatin
I. 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.
II. To determine the feasibility of the treatment regimen over the four courses of adjuvant chemotherapy once the MTD is estimated.
III. To assess the toxicities of the treatment regimen according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
I. To assess the response rate to this treatment regimen in patients with measurable disease.
II. To examine progression-free survival at one year on this treatment regimen. III. To examine overall survival. IV. To examine the location of recurrence, loco-regional versus distant for one year after completion of therapy.
V. To estimate the frequency of chronic toxicities experienced within one year of study entry.
OUTLINE: This is a dose-escalation study of carboplatin and paclitaxel.
Patients receive cisplatin intravenously (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295502
|United States, California|
|University of California Medical Center At Irvine-Orange Campus|
|Orange, California, United States, 92868|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|The Hospital of Central Connecticut|
|New Britain, Connecticut, United States, 06050|
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Ohio|
|Summa Akron City Hospital/Cooper Cancer Center|
|Akron, Ohio, United States, 44304|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Riverside Methodist Hospital|
|Columbus, Ohio, United States, 43214|
|Hillcrest Hospital Cancer Center|
|Mayfield Heights, Ohio, United States, 44124|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Cecelia Boardman||Gynecologic Oncology Group|