NCT01345279

Indirect Comparison Topotecan Cervical Carcinoma

Indirect Comparison of the Efficacy Between Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some differences between the respective study populations. Patients with prior chemotherapy were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in GOG-0169 (27%) than in GOG-0179 (\~60%) and these patients were unevenly distributed between treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated with the indirect meta-analysis.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	cisplatin	50 mg/m2 IV cisplatin on day 1 and then every 3 weeks for 6 courses
DRUG	topotecan	topotecan 0.75 mg/m2 on days 1, 2, and 3. The regimen was repeated every 3 weeks for 6 courses
DRUG	paclitaxel	135 mg/m2 paclitaxel on day 1 and then every 3 weeks for 6 courses

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2011-05-02
• Last updated: 2017-05-30