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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 : Completed
First Posted : December 28, 2012
Results First Posted : October 5, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Yuanyuan Zhang, University of Texas Southwestern Medical Center

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
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
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: PACLITAXEL (Phase II, Arm A)
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
Drug: PACLITAXEL
Experimental: NAB-PACLITAXEL (Phase II, Arm B)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Drug: NAB-PACLITAXEL
nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Other Name: Abraxan

Experimental: NAB-PACLITAXEL (Phase I)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
Drug: NAB-PACLITAXEL
nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
Other Name: Abraxan




Primary Outcome Measures :
  1. 2-year Overall Survival (Phase II) [ Time Frame: 2 years ]
    2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 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 ]
    The feasibility as measured by the number of participants who had 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 us defined as the completion of the treatment regimen with no more than minor variations.

  2. Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy [ Time Frame: 1,6,12,18,24 month ]
    The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria

  3. Proportion of Participants With Progression-free Survival (Phase II) [ Time Frame: 2 years ]
    Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method.

  4. Median Overall Survival (Phase II) [ Time Frame: every 6 months up to 24 months (approx. 22 months) ]
    Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

  5. EuroQol-5Dimension (EQ-5D) MUS Score at Baseline [ Time Frame: Baseline ]

    EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.

    Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."


  6. EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment [ Time Frame: End of treatment (6 weeks) ]

    EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.

    Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."


  7. EuroQol-5Dimension (EQ-5D) VAS Score at Baseline [ Time Frame: Baseline ]

    The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.

    Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.

    Possible score ranges from 0-100 with higher scores indicating better outcome.


  8. EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment [ Time Frame: End of Treatment (6 weeks) ]

    The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.

    Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.

    Possible score ranges from 0-100 with higher scores indicating better outcome.


  9. EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up [ Time Frame: 24 month follow up ]

    The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.

    Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.

    Possible score ranges from 0-100 with higher scores indicating better outcome.


  10. EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month [ Time Frame: 24 month follow up ]

    EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.

    Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."




Information from the National Library of Medicine

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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

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


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75239
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Celgene
Investigators
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Principal Investigator: Yuanyuan Zhang, MD University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Yuanyuan Zhang, University of Texas Southwestern Medical Center:
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Responsible Party: Yuanyuan Zhang, Instructor of Department of Radiation Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01757288    
Other Study ID Numbers: STU 062012-053
First Posted: December 28, 2012    Key Record Dates
Results First Posted: October 5, 2021
Last Update Posted: October 28, 2021
Last Verified: October 2021
Keywords provided by Yuanyuan Zhang, University of Texas Southwestern Medical Center:
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action