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

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Radiation: External beam radiation therapy; Drug: Paclitaxel poliglumex; Drug: Carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00352690

05-1195

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
  • Platelets ≥ 100,000/µl
  • Calculated Creatinine Clearance ≥ 20 cc/min
  • Bilirubin < 1.5 mg/dl
  • AST (SGOT) < 2 x ULN
  • INR > 0.8 < 1.2* *Values apply exclusively to patients not being treated with warfarin. Values for patients being treating with warfarin should fall within the following therapeutic range: > 2.0 < 3.0.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Cohort 1 (first 12 eligible patients)

Other group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel poliglumex

Radiation: External beam radiation therapy

Cohort 2 (remaining patients)

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel poliglumex

Radiation: External beam radiation therapy