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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Uterine Cervical Cancer

Treatments: Drug: albumin-bound paclitaxel plus nedaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01667211

11-92/527 (Other Identifier)

CH-GYN-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

albumin-bound paclitaxel plus nedaplatin

Experimental group

Description:

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.

Treatment:

Drug: albumin-bound paclitaxel plus nedaplatin