Study of Cisplatin in Cervical Cancer Stage IVB
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Chinese Anti-Cancer Association.
Recruitment status was: Not yet recruiting
Information provided by:
Chinese Anti-Cancer Association
First received: January 16, 2009
Last updated: January 20, 2009
Last verified: January 2009
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.
Drug: Cisplatin Combined With Topotecan
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer
Primary Outcome Measures:
- Response rate (CR + PR) (RECIST) [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity [NCI CTCAE (Version 3.0)] [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2010 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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No Contacts or Locations Provided
||xuan guo, Chinese Anti-Cancer Association
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 16, 2009
||January 20, 2009
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases
Genital Diseases, Female
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action