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Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

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ClinicalTrials.gov Identifier: NCT01757288
Recruitment Status : Recruiting
First Posted : December 28, 2012
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER Drug: NAB-PACLITAXEL Drug: PACLITAXEL Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : March 25, 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 2-year overall survival from randomization for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. the feasibility of concurrent carboplatin/nab-paclitaxel and radiation therapy [ Time Frame: 60 days of the start of treatment ]
    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.

  2. overall response rate for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
  3. the progression-free survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
  4. the median overall survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
  5. quality of life (QOL) of patients receiving either nab-paclitaxel or paclitaxel when given with concurrent radiotherapy [ Time Frame: 4 years ]
  6. correlate outcomes (survival, toxicity, QOL) with biological parameters [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757288


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

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen, MD    585-275-2171      
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Liza Villaruz, MD    877-470-7241      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: David Spigel, MD    877-691-7274      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Albert Attia, MD    877-936-8422      
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
Investigators
Principal Investigator: Hak Choy, MD University of Texas Southwestern Medical Center
More Information
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01757288     History of Changes
Other Study ID Numbers: STU 062012-053
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by University of Texas Southwestern Medical Center:
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
 Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action