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

Chinese Academy of Medical Sciences30 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Cervical Cancer

Interventions

albumin-bound paclitaxel plus nedaplatinDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

response rate

Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST

Time frame: one year

Secondary Outcomes

Time to progression (TTP)

Measure of time from study treatment to disease progression

Time frame: 2 years

2-year progression-free survival (PFS)

Percentage of patients who have PFS two years after receiving study treatment.

Time frame: 2 years

safety and tolerability

Percentage of patients who experience an adverse event during this study.

Time frame: 2 years

Overall survival (OS)

Measure of time from study treatment to patient's death or lost to follow-up.

Time frame: 5 years

Central Contacts

Rong Zhang

CONTACT

008613911982343 super0078888@sina.com

Data from ClinicalTrials.gov

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