Study of Cisplatin in Cervical Cancer Stage IVB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826891
Recruitment Status : Unknown
Verified January 2009 by Chinese Anti-Cancer Association.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
Information provided by:
Chinese Anti-Cancer Association

January 16, 2009
January 22, 2009
January 22, 2009
February 2009
January 2010   (Final data collection date for primary outcome measure)
Response rate (CR + PR) (RECIST) [ Time Frame: 4~6 weeks after the end of treatment ]
Same as current
No Changes Posted
Toxicity [NCI CTCAE (Version 3.0)] [ Time Frame: 4~6 weeks after the end of treatment ]
Same as current
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Study of Cisplatin in Cervical Cancer Stage IVB
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cervical Cancer
Drug: Cisplatin Combined With Topotecan

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

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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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xuan guo, Chinese Anti-Cancer Association
Chinese Anti-Cancer Association
Not Provided
Not Provided
Chinese Anti-Cancer Association
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP