Clinical trial NCT01667211: Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer
Official title: A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Uterine Cervical Cancer
Keywords: Advanced uterine cervical cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-08-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: response rate
timeFrame: one year
Secondary outcomes:
measure: Time to progression (TTP)
timeFrame: 2 years
measure: 2-year progression-free survival (PFS)
timeFrame: 2 years
measure: safety and tolerability
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Rong Zhang
role: PRINCIPAL_INVESTIGATOR
References: