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Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192036
First Posted: September 19, 2005
Last Update Posted: December 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: gemcitabine Drug: cisplatin Radiation: radiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Tumor Response at End of Treatment [ Time Frame: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation) ]
    Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.


Secondary Outcome Measures:
  • Time to Progressive Disease [ Time Frame: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years); ]
    Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.

  • Overall Survival [ Time Frame: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years) ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

  • Safety of Induction Chemotherapy [ Time Frame: every cycle (21 days) for 3 cycles (up to 10 weeks) ]
    A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.

  • Safety of Chemo-radiotherapy [ Time Frame: Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy ]
    A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.


Enrollment: 49
Study Start Date: August 2004
Study Completion Date: November 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Cisplatin

Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).

Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.

Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.

Drug: gemcitabine
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)
Other Names:
  • LY188011
  • Gemzar
Drug: cisplatin
80 mg/m2, IV, every 21 days x 5 cycles
Radiation: radiation
63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable non small cell lung cancer Stage III
  • Adequate hematological parameters
  • Adequate Lung function reserve

Exclusion Criteria:

  • Previous chemotherapy and thoracic radiation for non small cell lung cancer
  • Presence of distant metastases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192036


Locations
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aalst, Belgium, 9300
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Charleroi, Belgium, 6000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gilly, Belgium, 6060
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Haine-St.- Paul, Belgium, 7100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Herentals, Belgium, 2200
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mechelen, Belgium, 2800
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottignies, Belgium, 1340
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Turnhout, Belgium, 2300
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00192036     History of Changes
Other Study ID Numbers: 8984
B9E-BX-JHSQ ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: February 23, 2009
Results First Posted: March 25, 2009
Last Update Posted: December 9, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs