Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

NCT00449657 | Terminated Phase 2

• 1 other identifier: LJCC 07-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response using RECIST criteria

  12/31/2014

Secondary Outcomes (3)

• Locoregional control

  12/31/2014

• Distant failure

  12/31/2014

• Progression free survival

  12/31/2014

Interventions

Taxol (paclitaxel) DRUG

paclitaxel 15mg/m2 Q am on Mon/Wed/Fri

Radiotherapy PROCEDURE

Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before. Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5

Carboplatin DRUG

Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 \& 9

Gemcitabine DRUG

Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 \& 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.
• Patients will be included in the study based on the following criteria:
• Patients must be older than 18 years old.
• Patients must have a Zubrod performance status of 0 to 2
• Patients with adequate bone marrow function
• Patients with adequate renal function
• Patients with adequate hepatic function
• Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
• Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
• Patients who have signed an approved informed consent and authorization permitting release of personal health information.

You may not qualify if:

• Superior sulcus tumors
• Atelectasis or obstructive pneumonitis of the entire lung
• Malignant pleural effusion
• Surgical candidates
• Patients who are pregnant at the time of diagnosis
• Serious concomitant systemic disorders incompatible with the study
• Inability to comply with study and/or follow-up procedures
• Life expectancy of less than 12 weeks
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
• Patients with septicemia or severe infection.
• Patients who have circumstances that will not permit completion of this study or the required follow-up
• Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (16)

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  PMID: 12631594 BACKGROUND

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  PMID: 24246506 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Radiotherapy; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Paul Walker, MD

  Brody School of Medicine at East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 20, 2007
• Study Start: February 1, 2007
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (1)