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Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

NCT00191139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2010-02-17

Study results available
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Summary

To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.

Conditions

Interventions

DRUG

gemcitabine

After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.

DRUG

docetaxel

Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

DRUG

cisplatin

As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)

DRUG

etoposide

As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)

RADIATION

radiation therapy

In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2008-11-30
Completion
2009-02-28

Countries

  • United States
  • Argentina
  • China
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191139 on ClinicalTrials.gov