Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.

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Detailed Description

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Nanoparticle albumin-bound paclitaxel (nab-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. A multicenter randomized controled trial (coded as CA031) showed that nab-paclitaxel in combination with carboplatin had higher response rate than traditional paclitaxel plus carboplatin, especially in squamous lung cancer. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer after failure of platinum-based doublet therapy.

Conditions

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Squamous Cell Carcinoma of Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nanoparticle albumin-bound paclitaxel

Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Group Type EXPERIMENTAL

nanoparticle albumin-bound paclitaxel

Intervention Type DRUG

Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Interventions

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nanoparticle albumin-bound paclitaxel

Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Intervention Type DRUG

Other Intervention Names

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Abraxane, nab-paclitaxel

Eligibility Criteria

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Inclusion Criteria

1. Signed informed-consent form;
2. Age no less than 18 years;
3. Histologically confirmed locally advanced or metastatic squamous lung cancer;
4. Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
5. RECIST measurable lesions;
6. Disease progression after failure of platinum-based doublet therapy;
7. Adequate liver/renal/bone marrow function;
8. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
9. Compliance, and can be followed up regularly.

Exclusion Criteria

1. Pregnant or breast-feeding female, or not willing to take contraception measures during study;
2. Radiotherapy within 30 days, systematic therapy within 21 days;
3. Serious infection requiring antibiotics intervention during recruitment;
4. Allergic to study drug;
5. Require concurrent biological target therapy;
6. More than grade 1 neuropathy;
7. Uncontrolled brain metastasis or mental illness;
8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
9. Other malignancy within 5 years;
10. Can't be followed up or obey protocol;
11. Ineligible by the judge of the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No