Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix.
Drug: cisplatin plus paclitaxel
Drug: gemcitabine hydrochloride
Drug: topotecan hydrochloride
Drug: vinorelbine tartrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix|
- Quality of life as measured by change in the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment [ Time Frame: baseline, courses 2 and 5, 9 months after completion of study treatment ] [ Designated as safety issue: Yes ]
- Brief Pain Inventory change from baseline [ Time Frame: baseline, courses 2 and 5, 9 months after completion of study treatment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Regimen I
paclitaxel plus cisplatin
|Drug: cisplatin plus paclitaxel|
Active Comparator: Regimen II
|Drug: vinorelbine tartrate|
Active Comparator: Regimen III
|Drug: gemcitabine hydrochloride|
Active Comparator: Regimn IV
|Drug: topotecan hydrochloride|
- Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
- Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
- Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064077
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|Study Chair:||Bradley J. Monk, MD||Chao Family Comprehensive Cancer Center|