Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer

Study Overview
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Brief Summary
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Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.

Detailed Description
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Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be completed.

Official Title
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A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer

Conditions
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Uterine Cervical Cancer

Intervention / Treatment
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* Drug: albumin-bound paclitaxel plus nedaplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical cancer, advanced or recurrent metastasis Measurable and assessible tumor lesions Used ordinary paclitaxel or platinum drugs, more than 28 days Aged 18-70 KPS score> 60 points, expected to survive more than 3 months Normal bone marrow function The function of liver and kidney had no obvious damage Normal function of vital organs No brain metastases Patients or their agents to sign informed consent Compliance, and can be followed up regularly Exclusion Criteria: Brain metastases Serious complications Acute inflammatory response Combined with other tumor Pregnancy or breast-feeding women Vertebral metastasis with nerve compression symptoms Large volume of pleural effusion, pericardial effusion Other malignancy within five years Drug allergy Other chemotherapy contraindications The possibility of pregnancy, and not willing to contraception No measurement of lesion Mental illness which is difficult to control

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albumin-bound paclitaxel plus nedaplatin<br>albumin-bound paclitaxel plus nedaplatin: Intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed. | Drug: albumin-bound paclitaxel plus nedaplatin<br>* intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.<br>* Other names: Abraxane (albumin-bound paclitaxel);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) | Measure of time from study treatment to disease progression | 2 years | 
| 2-year progression-free survival (PFS) | Percentage of patients who have PFS two years after receiving study treatment. | 2 years | 
| safety and tolerability | Percentage of patients who experience an adverse event during this study. | 2 years | 
| Overall survival (OS) | Measure of time from study treatment to patient's death or lost to follow-up. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced uterine cervical cancer