Study of Cisplatin in Cervical Cancer Stage IVB

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Cisplatin Combined With Topotecan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (CR + PR) (RECIST) |  | 4 6 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity [NCI CTCAE (Version 3.0)] |  | 4 6 weeks after the end of treatment |