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

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Treatments: Drug: NAB-PACLITAXEL; Drug: PACLITAXEL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01757288

STU 062012-053

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

PACLITAXEL (Phase II, Arm A)

Active Comparator group

Description:

PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY

Treatment:

Drug: PACLITAXEL

NAB-PACLITAXEL (Phase II, Arm B)

Experimental group

Description:

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

Treatment:

Drug: NAB-PACLITAXEL

Drug: NAB-PACLITAXEL

NAB-PACLITAXEL (Phase I)

Experimental group

Description:

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

Treatment:

Drug: NAB-PACLITAXEL

Drug: NAB-PACLITAXEL