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

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

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

Study Overview

• Status: Unknown
• Conditions: Uterine Cervical Cancer
• Intervention / Treatment: Drug: albumin-bound paclitaxel plus nedaplatin

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology
    • Contact: Rong Zhang; Phone Number: 008613911982343; Email: super0078888@sina.com
    • Principal Investigator: Rong Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Abraxane (albumin-bound paclitaxel)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Rong Zhang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Advanced uterine cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel; Nedaplatin
• Other Study ID Numbers: CH-GYN-001; 11-92/527 (Other Identifier: Cancer Institute and Hospital, CAMS)