Indirect Comparison Topotecan Cervical Carcinoma

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345279
• Other study ID #: 114016
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: May 25, 2017
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• randomised clinical trials, or systematic reviews and meta-analyses

• treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		12 months