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

Phase 2

• Conditions: Uterine Cervical Cancer
• Interventions: Drug: albumin-bound paclitaxel plus nedaplatin

• Registration Number: NCT01667211
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-07-10
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
albumin-bound paclitaxel plus nedaplatin	albumin-bound paclitaxel plus nedaplatin	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.

Primary Outcome Measures

Name	Time	Method
response rate	one year	Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology; 🇨🇳 Beijing, China