Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by First People's Hospital of Hangzhou
Sponsor:
Information provided by (Responsible Party):
Shenglin Ma, First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier:
NCT01494415
First received: December 14, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Drug: Paclitaxel for Injection(Albumin Bound)
Drug: carboplatin
Radiation: thoracic radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by First People's Hospital of Hangzhou:

Primary Outcome Measures:
  • tumor response rate [ Time Frame: one month after the end of all treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 2 years from patient enrollment ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 2 years from patient enrollment ] [ Designated as safety issue: Yes ]
  • esophagitis [ Time Frame: 6 mouths from the initiation of treatment ] [ Designated as safety issue: Yes ]
    acute esophagitis of Grade III and above


Estimated Enrollment: 21
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemoradiotherapy
This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
Drug: Paclitaxel for Injection(Albumin Bound)
concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
Other Name: Abraxane®
Drug: carboplatin
concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks
Radiation: thoracic radiation therapy
66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed

Detailed Description:

This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
  • Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
  • Weight loss ≦ 5% in the previous six months.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer.
  • Patient has previously had thoracic radiation therapy.
  • Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
  • Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • History of significant neurological or mental disorder, including seizures or dementia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494415

Contacts
Contact: Bing Xia, MD, PhD 86 18857110928 bxia_hzch@hotmail.com

Locations
China, Zhejiang
The First People's Hospital of Hangzhou Active, not recruiting
Hangzhou, Zhejiang, China, 310006
Hangzhou Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310002
Contact: Bing Xia, MD    0571-56006035    bxia_hzch@hotmail.com   
Principal Investigator: Bing Xia, MD         
Sponsors and Collaborators
First People's Hospital of Hangzhou
Investigators
Principal Investigator: Shenglin Ma, MD The First People's Hospital of Hangzhou
  More Information

No publications provided

Responsible Party: Shenglin Ma, President of the hospital, First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT01494415     History of Changes
Other Study ID Numbers: HZFH CA11-01
Study First Received: December 14, 2011
Last Updated: August 6, 2014
Health Authority: China: Ethics Committee

Keywords provided by First People's Hospital of Hangzhou:
Squamous Cell Lung Cancer
radiation therapy
chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014