Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Chinese Anti-Cancer Association |
---|---|
Information provided by: | Chinese Anti-Cancer Association |
ClinicalTrials.gov Identifier: | NCT00826891 |
This is a single arm, open-label study in women from China who have Advanced (stage IVB) Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical cancer. Prior to treatment, written informed consent should be obtained from all patients. Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every 21 days. The study will consist of two phases: the safety run-in phase and study phase.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: Cisplatin Combined With Topotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Patients must have specific minimum neutrophil and platelet counts before administration of Hycamtin. The dose of Hycamtin is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course). Dosage adjustments for subsequent courses of Hycamtin in combination with cisplatin are specific for each drug.
Dose levels for cisplatin Initial dose 0 = 50 mg/m2 Dose reduction level -1 = 37.5 mg/m2 Dose reduction level -2 = 25 mg/m2
Dose levels for topotecan Initial dose 0 = 0.75 mg/m2 Dose reduction level -1 = 0.60 mg/m2 Dose reduction level -2 = 0.45 mg/m2
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Chinese Anti-Cancer Association ( xuan guo ) |
Study ID Numbers: | CACA-2008-GSK1 |
Study First Received: | January 16, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00826891 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Radiation-Sensitizing Agents Cisplatin Topotecan Recurrence |
Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Topotecan Pharmacologic Actions |