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| ID | Type | Description | Link |
|---|---|---|---|
| 11-92/527 | Other Identifier | Cancer Institute and Hospital, CAMS |
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Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albumin-bound paclitaxel plus nedaplatin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin-bound paclitaxel plus nedaplatin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression (TTP) | Measure of time from study treatment to disease progression | 2 years |
| 2-year progression-free survival (PFS) | Percentage of patients who have PFS two years after receiving study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Zhang | Contact | 008613911982343 | super0078888@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Zhang | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology | Recruiting | Beijing | 100021 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
|
| 2 years |
| safety and tolerability | Percentage of patients who experience an adverse event during this study. | 2 years |
| Overall survival (OS) | Measure of time from study treatment to patient's death or lost to follow-up. | 5 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |