Status:
UNKNOWN
Study of Cisplatin in Cervical Cancer Stage IVB
Lead Sponsor:
Chinese Anti-Cancer Association
Conditions:
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00826891
Start Date
February 1 2009
End Date
January 1 2010
Last Update
January 22 2009
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