Uterine Cervical Cancer
Conditions
Keywords
Advanced uterine cervical cancer
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.
Interventions
DRUGalbumin-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.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | one year | Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| safety and tolerability | 2 years | Percentage of patients who experience an adverse event during this study. |
| Overall survival (OS) | 5 years | Measure of time from study treatment to patient's death or lost to follow-up. |
Countries
China
Contacts
Primary ContactRong Zhang
Outcome results
None listed