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A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
This study has been terminated.
( Safety of patients )
First Received: July 14, 2006   Last Updated: February 2, 2009   History of Changes
Sponsors and Collaborators: Washington University School of Medicine
Cell Therapeutics
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00352690
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: paclitaxel poliglumex
Drug: carboplatin
Procedure: radiation therapy
Drug: Xyotax
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the rates of overall survival for patients treated with paclitaxel poliglumex, carboplatin and thoracic RT. [ Time Frame: Completion of 12 evaluable patients ] [ Designated as safety issue: Yes ]
  • To determine the failure-free survival and response rates for patients treated with radiation therapy, paclitaxel poliglumex and carboplatin. [ Time Frame: Completion of 12 evaluable patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the incidence and severity of radiation-induced esophagitis and pneumonitis in this population. [ Time Frame: After 12 evaluable patients ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: February 2006
Estimated Study Completion Date: August 2009
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
one cohort of 6 patients and one expanded cohort of 6 at a dose level of 135 mg/m2 of paclitaxel poliglumex, and one cohort of 6 at a dose level of 175 mg/m2.
Drug: paclitaxel poliglumex
135 mg/m2 intravenously over 10 minutes on day 1 of each 21-day cycle for a total of 2 cycles
Drug: carboplatin
Carboplatin AUC = 5** by IV over 30 minutes (note that carboplatin is calculated using actual (not ideal) body weight on day 1 of each 21-day cycle for a total of 2 cycles.
Procedure: radiation therapy
You will receive radiation therapy every day for about 6-7 weeks (for a total of 33 days on a Monday through Friday schedule.After your radiation treatment ends, you will take a 3-5 week break.
Drug: Xyotax
135 mg/m2 of paclitaxel poliglumex, and 175 mg/m2 if tolerated at lower dose.

Detailed Description:

Non-surgical candidates

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352690

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Cell Therapeutics
Investigators
Principal Investigator: Ramaswamy Govindan, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine ( Ramaswamy Govindan, M.D. )
Study ID Numbers: 05-1195
Study First Received: July 14, 2006
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00352690     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Thoracic Neoplasms
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009