TerminatedPhase 2NCT00449657

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

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

Checked against the public recordLast updated Mar 14, 2018 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorLeo W. Jenkins Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Leo W. Jenkins Cancer Center
Interventions being studied
Drug: Taxol (paclitaxel); Procedure: Radiotherapy; Drug: Carboplatin; Drug: Gemcitabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1. Disease-Specific Exclusions * Superior sulcus tumors * Atelectasis or obstructive pneumonitis of the entire lung * Malignant pleural effusion 2. General Medical Exclusions * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Brody School of Medicine at East Carolina UniversityGreenville, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 14, 2018. Always confirm current availability with the study team.

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