Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
This study is currently recruiting participants.
Verified July 2016 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01757288
First Posted: December 28, 2012
Last Update Posted: July 15, 2016
Collaborator:
Celgene
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
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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 |
|---|---|---|
| STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER | Drug: NAB-PACLITAXEL Drug: PACLITAXEL | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
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 ]
Secondary Outcome Measures:
- 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.
- overall response rate for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
- the progression-free survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
- the median overall survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy [ Time Frame: 4 years ]
- quality of life (QOL) of patients receiving either nab-paclitaxel or paclitaxel when given with concurrent radiotherapy [ Time Frame: 4 years ]
- correlate outcomes (survival, toxicity, QOL) with biological parameters [ Time Frame: 4 years ]
| Estimated Enrollment: | 98 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2016 (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
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| 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
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
| Responsible Party: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01757288 History of Changes |
| Other Study ID Numbers: |
STU 062012-053 |
| First Submitted: | December 20, 2012 |
| First Posted: | December 28, 2012 |
| Last Update Posted: | July 15, 2016 |
| Last Verified: | July 2016 |
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 |