A Phase I/II Study of Nab-Paclitaxel, or Paclitaxel, Plus Carboplatin With Concurrent Radiation Therapy Followed by Consolidation in Patients With Favorable Prognosis Inoperable Stage IIIA/B NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01757288
First received: December 20, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with with carboplatin concurrent with daily radiation.


Condition Intervention Phase
INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER
Drug: NAB-PACLITAXEL
Drug: PACLITAXEL
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 2-year overall survival from randomization for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the feasibility of concurrent carboplatin/nab-paclitaxel and radiation therapy [ Time Frame: 60 days of the start of treatment ] [ Designated as safety issue: Yes ]
    Safety is measured by the rate of grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance is defined as the completion of the treatment regimen with no more than minor variations.

  • overall response rate for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • the progression-free survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • the median overall survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • quality of life (QOL) of patients receiving either nab-paclitaxel or paclitaxel when given with concurrent radiotherapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • correlate outcomes (survival, toxicity, QOL) with biological parameters [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: March 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PACLITAXEL
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
Drug: PACLITAXEL
Experimental: NAB-PACLITAXEL
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
Drug: NAB-PACLITAXEL
Other Name: Abraxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
  • Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
  • Patients with Zubrod performance status 0-1
  • Adequate hematologic function
  • FEV1 with ≥ 1200 cc or ≥ 50% predicted

Exclusion Criteria:

  • Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
  • Exudative, bloody, or cytologically malignant effusions
  • Prior therapy with any molecular targeted drugs (for lung cancer)
  • Active pulmonary infection not responsive to conventional antibiotics
  • Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  • Patients with > grade 1 neuropathy
  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: NCT01757288

Contacts
Contact: Hak Choy, MD 214-645-8525
Contact: Jean Wu, MSN 214-633-1753

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75239
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Celgene Corporation
Investigators
Principal Investigator: Hak Choy, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01757288     History of Changes
Other Study ID Numbers: STU 062012-053
Study First Received: December 20, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
INOPERABLE LUNG CANCER
STAGE IIIA/B NON-SMALL CELL LUNG CANCER

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
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 20, 2014