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.
Verified March 2013 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
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: March 25, 2013
Last verified: March 2013
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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 |
|---|---|---|
|
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
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: | March 25, 2013 |
| 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 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013