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Trial Title:
Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer
NCT ID:
NCT01667211
Condition:
Uterine Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Nedaplatin
Conditions: Keywords:
Advanced uterine cervical cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
albumin-bound paclitaxel plus nedaplatin
Description:
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.
Arm group label:
albumin-bound paclitaxel plus nedaplatin
Other name:
Abraxane (albumin-bound paclitaxel)
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Zhang
Phone:
008613911982343
Email:
super0078888@sina.com
Investigator:
Last name:
Rong Zhang
Email:
Principal Investigator
Start date:
November 2011
Completion date:
December 2016
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01667211
