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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rates of overall survival for patients treated with paclitaxel poliglumex, carboplatin and thoracic RT.

Outcome Time Frame:

Every 3 months for 1 year, every 6 months for years 2-3, and then at the end of year 4

Safety Issue:


Principal Investigator

Ramaswamy Govindan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110
Washington Hospital Center Washington, District of Columbia  20010
University of California, San Francisco San Francisco, California  94143
SUNY Upstate Medical University Syracuse, New York  13210
University Of Kansas Kansas City, Kansas  66160
Rush University Medical College Chicago, Illinois  
University of Minnesota, Twin Cities Minneapolis, Minnesota  
University of Missouri, Columbia Columbia, Missouri  65211