MedDataX Logo

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

NCT ID: NCT01667211

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Advanced uterine cervical cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

albumin-bound paclitaxel plus nedaplatin

albumin-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.

Group Type EXPERIMENTAL

albumin-bound paclitaxel plus nedaplatin

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

albumin-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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abraxane (albumin-bound paclitaxel)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhang rong

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rong Zhang

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rong Zhang

Role: CONTACT

Phone: 008613911982343

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rong Zhang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-92/527

Identifier Type: OTHER

Identifier Source: secondary_id

CH-GYN-001

Identifier Type: -

Identifier Source: org_study_id