Study of Cisplatin in Cervical Cancer Stage IVB - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 16, 2009
Last Updated Date	January 20, 2009
Start Date ^†	February 2009
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	Response rate (CR + PR) (RECIST) [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00826891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: January 21, 2009)	Toxicity [NCI CTCAE (Version 3.0)] [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Study of Cisplatin in Cervical Cancer Stage IVB
Official Title ^†	Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Cervical Cancer
Intervention ^†	Drug: Cisplatin Combined With Topotecan
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Not yet recruiting
Estimated Enrollment ^†	40
Estimated Completion Date	January 2010
Estimated Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: women with advanced recurrent or persistent carcinoma of the uterine cervical who were unsuitable candidates for curative treatment with surgery and/or radiotherapy. Histologic types included squamous, adenosquamous, and adenocarcinoma of the cervia. Patients must be at least 18 years old. Measurable and/or evaluable disease parameters will be documented and recorded using clinical evaluation (and using CT for pathologic nodes when present). Life expectation greater than 3 months. Patients must have adequate organ function. Patients without history of sensitivity to camptothecin or platinum. Patients who are non-child-bearing potential, or consistent and correct use of methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of observational medication. performance status 0 to 2; to have recovered from the effects of recent surgery, chemoradiotherapy, or radiotherapy; and to be free of clinically significant infection. Written informed consent Exclusion Criteria: Patients with uncontrolled infections. Patients with concurrent severe medical problems unrelated to the malignancy which would expose the patient to extreme risk. Patients who received another investigational drug within 30 days prior to study entry. Patients who are receiving concurrent other chemotherapy, hormonal, immunotherapy or radiotherapy. Radiotherapy for palliation of related bone metastases is permitted. Patients with a history of allergic reactions to compounds chemically related to topotecan or platinum. Patients who are pregnant or lactating Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826891
Responsible Party	xuan guo, Chinese Anti-Cancer Association
Secondary IDs ^††
Study Sponsor ^†	Chinese Anti-Cancer Association
Collaborators ^††
Investigators ^†
Information Provided By	Chinese Anti-Cancer Association
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.