Docetaxel and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer
3 other identifiers
interventional
106
1 country
17
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
Started Feb 1999
Longer than P75 for phase_2 lung-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 2, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedFirst Posted
Study publicly available on registry
June 24, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJuly 13, 2016
July 1, 2016
4 years
May 2, 2000
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
Up to 5 years
Secondary Outcomes (1)
quality of life
Up to 5 years
Study Arms (3)
Arm I: docetaxel + gemcitabine
EXPERIMENTALPatients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Arm II: docetaxel + gemcitabine
EXPERIMENTALPatients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Arm III: docetaxel + gemcitabine
EXPERIMENTALPatients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (17)
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131, United States
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, 58501, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122, United States
Altru Health Systems
Grand Forks, North Dakota, 58201, United States
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, 17822-2001, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709, United States
Related Publications (2)
Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444.
PMID: 17211864BACKGROUNDJatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.
PMID: 16361618BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edith A. Perez, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2000
First Posted
June 24, 2004
Study Start
February 1, 1999
Primary Completion
February 1, 2003
Study Completion
May 1, 2008
Last Updated
July 13, 2016
Record last verified: 2016-07