Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer
Uterine Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Advanced uterine cervical cancer
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: albumin-bound paclitaxel plus nedaplatin
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology
Beijing, China
Status: Recruiting
Contact: Rong Zhang - 008613911982343 -
Start Date
November 2011
Completion Date
December 2016
Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Record processing date processed this data on July 28, 2015 page