A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel poliglumex
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Washington University School of Medicine
- Enrollment
- 10
- Locations
- 8
- Primary Endpoint
- Overall Survival (OS)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas).
- •Eligible Disease Stages: Inoperable IIIA and Selected IIIB
- •Local radiation oncologist must approve patient eligibility prior to entry on study.
- •Patients must have measurable disease.
- •Prior Therapy:
- •≥ 2 weeks since formal exploratory thoracotomy.
- •No prior chemotherapy or radiation therapy for NSCLC.
- •ECOG performance status 0-1
- •Required Initial Laboratory Values (must be submitted within 16 days prior to registration):
- •Granulocytes ≥ 1,500/µl
Exclusion Criteria
- •Currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- •Pregnant or nursing because of significant risk to the fetus/infant.
- •Age \<18 years.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •No HIV-positive patients receiving combination anti-retroviral therapy. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
- •One-second forced expiratory volume (FEV1) \<50% or hemoglobin-corrected carbon monoxide diffusion capacity (DLCO) \<50% of predicted, as measured within 21 days of study entry
- •Symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow solid food) within 4 weeks prior to study randomization. Patients must not require prophylactic placement of percutaneous enterogastrostomy (PEG) tube or other non-oral nutritional supplement methods
- •Weight loss of \> 10% in the past 3 months.
Arms & Interventions
Cohort 1 (first 12 eligible patients)
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.
Intervention: Paclitaxel poliglumex
Cohort 1 (first 12 eligible patients)
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.
Intervention: Carboplatin
Cohort 1 (first 12 eligible patients)
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.
Intervention: External beam radiation therapy
Cohort 2 (remaining patients)
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.
Intervention: Paclitaxel poliglumex
Cohort 2 (remaining patients)
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.
Intervention: Carboplatin
Cohort 2 (remaining patients)
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.
Intervention: External beam radiation therapy
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Completion of follow-up (follow-up ranged from 3 months to 6 years)
OS = time from patient registration to death of all causes
Overall Survival (OS) Rate
Time Frame: 6 months
* OS = time from patient registration to death of all causes * Estimated using Kaplan Meier
Secondary Outcomes
- Response Rates(4 years)
- Incidence and Severity of Radiation-induced Esophagitis(30 days following completion of treatment (approximately 114 days))
- Failure-free Survival (FFS) Rate(6 months)
- Failure-free Survival (FFS)(Completion of follow-up (follow-up ranged from 3 months to 6 years))
- Incidence and Severity of Radiation-induced Pneumonitis(30 days following completion of treatment (approximately 114 days))