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A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Uterine Cervical Cancer

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Trial Information

A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Description:

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

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Rong Zhang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CH-GYN-001

NCT ID:

NCT01667211

Start Date:

November 2011

Completion Date:

December 2016

Related Keywords:

  • Uterine Cervical Cancer
  • Advanced uterine cervical cancer
  • Uterine Cervical Neoplasms

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