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

Uterine Cervical Cancer Clinical Trial

— CSAPPPCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01667211
• Other study ID #: CH-GYN-001
• Secondary ID: 11-92/527
• Status: Recruiting
• Phase: Phase 2
• First received: July 10, 2012
• Last updated: August 21, 2012
• Start date: November 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2012
• Source: Chinese Academy of Medical Sciences
• Contact: Rong Zhang
• Phone: 008613911982343
• Email: super0078888[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST	one year	No
Secondary	Time to progression (TTP)	Measure of time from study treatment to disease progression	2 years	No
Secondary	2-year progression-free survival (PFS)	Percentage of patients who have PFS two years after receiving study treatment.	2 years	No
Secondary	safety and tolerability	Percentage of patients who experience an adverse event during this study.	2 years	Yes
Secondary	Overall survival (OS)	Measure of time from study treatment to patient's death or lost to follow-up.	5 years	Yes