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

NCT01757288 | Completed Phase 1 Results DMC

• 1 other identifier: STU 062012-053
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 5

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.

Conditions

STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Keywords

STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Outcome Measures

Primary Outcomes (1)

• 2-year Overall Survival (Phase II)

  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.

  2 years

Secondary Outcomes (10)

• The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy

  60 days of the start of treatment

• Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy

  1,6,12,18,24 month

• Proportion of Participants With Progression-free Survival (Phase II)

  2 years

• Median Overall Survival (Phase II)

  every 6 months up to 24 months (approx. 22 months)

• EuroQol-5Dimension (EQ-5D) MUS Score at Baseline

  Baseline

Study Arms (3)

PACLITAXEL (Phase II, Arm A)

ACTIVE COMPARATOR

PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY

Drug: PACLITAXEL

NAB-PACLITAXEL (Phase II, Arm B)

EXPERIMENTAL

NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks

Drug: NAB-PACLITAXEL

NAB-PACLITAXEL (Phase I)

EXPERIMENTAL

NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Drug: NAB-PACLITAXEL

Interventions

NAB-PACLITAXEL DRUG

nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Also known as: Abraxan

NAB-PACLITAXEL (Phase I)

PACLITAXEL DRUG

PACLITAXEL (Phase II, Arm A)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Celgene: collaborator

Study Sites (5)

University of Rochester

Rochester, New York, 14642, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

For Quality of life endpoints, we were limited by the log questionnaire completion rate. The number of patients completed quality of life questionnaire ranged from 1-8 patients in each are at month 3,6,9,12. Additionally, there was a high rate of missing data for FACT series questionnaire. As a result, we are reporting EQ-5D result at baseline and end of treatment. The responsible party Dr. Hak Choy has been replaced with the Yuanyuan Zhang as Dr. Choy has left UTSouthwestern Medical Center.

Results Point of Contact

• Title: Dr. Yuanyuan Zhang
• Organization: UT Southwestern Medical Center

Yuanyuan.Zhang@UTSouthwestern.edu

214-648-6764

Study Officials

• Yuanyuan Zhang, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Department of Radiation Oncology

Model Details: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: March 25, 2013
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: October 28, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-10

Locations

US (5)