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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00064077 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: topotecan hydrochloride Drug: vinorelbine ditartrate |
Phase III |
| MedlinePlus related topics: | Cancer Cervical Cancer |
| Drug Information available for: | Cisplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Paclitaxel Topotecan hydrochloride Topotecan |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations![]() |
Show 172 Study Locations |
| Gynecologic Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Monk BJ, Sill M, McMeekin DS, et al.: A randomized phase III trial of four cisplatin (CIS) containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5504, 2008.
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Wenzel LB, Huang H, Cella D, et al.: Quality-of-life results of a randomized phase III trial of four cisplatin (Cis) containing doublet combinations in stage IVB cervical carcinoma: A gynecologic oncology group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-5529, 2008.
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| Study ID Numbers: | CDR0000306463, GOG-0204 |
| First Received: | July 8, 2003 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00064077 |
| Health Authority: | United States: Federal Government |
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