Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Paclitaxel poliglumex

Tubulin Modulators

Antimitotic Agents

Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

External beam radiation therapy

Ramaswamy Govindan, M.D.

This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.

A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

* OS = time from patient registration to death of all causes
* Estimated using Kaplan Meier

OS = time from patient registration to death of all causes

* The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)
* Estimated using Kaplan Meier

The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)

CTI BioPharma

Washington University School of Medicine

Cohort 1 (First 12 Eligible Patients)

Cohort 2 (Remaining Patients)

Total

Age, Continuous

Gender

United States

Region of Enrollment

(3) grade 5 serious adverse events occurred and led to the study closing early for the safety of participants.

Participants with unknown expiration dates were censored at the date of last clinical contact.

Overall Survival (OS) Rate

Participants with unknown event dates were censored at the date of last clinical contact.

Spots Global Cancer Trial Database for A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial