- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826891
Study of Cisplatin in Cervical Cancer Stage IVB
January 20, 2009 updated by: Chinese Anti-Cancer Association
Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (CR + PR) (RECIST)
Time Frame: 4~6 weeks after the end of treatment
|
4~6 weeks after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity [NCI CTCAE (Version 3.0)]
Time Frame: 4~6 weeks after the end of treatment
|
4~6 weeks after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Anticipated)
January 1, 2010
Study Completion (Anticipated)
January 1, 2010
Study Registration Dates
First Submitted
January 16, 2009
First Submitted That Met QC Criteria
January 20, 2009
First Posted (Estimate)
January 22, 2009
Study Record Updates
Last Update Posted (Estimate)
January 22, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Topotecan
Other Study ID Numbers
- CACA-2008-GSK1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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