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Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00145418
Recruitment Status : Terminated (low enrollment)
First Posted : September 5, 2005
Results First Posted : January 31, 2013
Last Update Posted : June 30, 2014
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Intervention Drug: Oxaliplatin + Docetaxel
Enrollment 15
Recruitment Details patients recruited from clinical practice.
Pre-assignment Details patients were screened to see if they met eligibility criteria. If criteria met, enrolled into study. Otherwise listed as screen failures.
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  53.3%
>=65 years
7
  46.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Response Rate
Time Frame Response is measured every 2 cycles until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description:
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
partial response 7
complete response 0
stable disease 1
2.Secondary Outcome
Title Time to Progression
Hide Description Progression is measured from each participants start of study until removal from treatment.
Time Frame <1 cycle to 6 cycles of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description:
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: months
2.4
(0 to 6)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is a measure of how long the participants response to therapy was maintained.
Time Frame 0 -12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description:
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: months
7.9
(0 to 12)
4.Secondary Outcome
Title Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.
Hide Description Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.
Time Frame day one of cycle one until participant removed from trial
Hide Outcome Measure Data
Hide Analysis Population Description
all participants had adverse events
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description:
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Grade 3 or 4 anemia 1
grade 3 or 4 thrombocytopenia 1
Grade 3 or 4 fatigue 5
Grade 3 or 4 dehydration 2
Grade 3 or 4 nausea 1
Grade 3 or 4 diarrhea 2
Grade 3 or 4 anorexia 1
Grade 3 or 4 neutropenia 3
Grade 3 or 4 vomiting 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxaliplatin + Docetaxel
Hide Arm/Group Description Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
All-Cause Mortality
Oxaliplatin + Docetaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin + Docetaxel
Affected / at Risk (%) # Events
Total   9/15 (60.00%)    
Blood and lymphatic system disorders   
DVT   1/15 (6.67%)  1
Cardiac disorders   
pericardial effusion   1/15 (6.67%)  1
Gastrointestinal disorders   
Dehydration   2/15 (13.33%)  2
nausea   1/15 (6.67%)  1
clostridium difficile colitis   1/15 (6.67%)  1
diarrhea *  1/15 (6.67%)  1
General disorders   
fatigue   1/15 (6.67%)  1
Infections and infestations   
Catheter infection   1/15 (6.67%)  1
sepsis   1/15 (6.67%)  1
Injury, poisoning and procedural complications   
concussion   1/15 (6.67%)  1
Nervous system disorders   
pain *  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
hemoptysis   1/15 (6.67%)  1
chest pain *  1/15 (6.67%)  1
dyspnea   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxaliplatin + Docetaxel
Affected / at Risk (%) # Events
Total   15/15 (100.00%)    
Blood and lymphatic system disorders   
anemia   12/15 (80.00%)  12
neutropenia   6/15 (40.00%)  6
Gastrointestinal disorders   
Nausea *  10/15 (66.67%)  10
vomiting *  2/15 (13.33%)  2
diarrhea *  6/15 (40.00%)  6
constipation *  1/15 (6.67%)  1
General disorders   
fatigue *  7/15 (46.67%)  7
Metabolism and nutrition disorders   
anorexia *  3/15 (20.00%)  3
dehydration   3/15 (20.00%)  3
Nervous system disorders   
Headache *  6/15 (40.00%)  6
dysguesia *  5/15 (33.33%)  5
neuropathy   12/15 (80.00%)  12
Skin and subcutaneous tissue disorders   
alopecia   5/15 (33.33%)  5
rash   1/15 (6.67%)  1
Vascular disorders   
thrombocytopenia   5/15 (33.33%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Due to lack of recruitment, the study was closed early and conclusions should not necessarily be drawn from the data presented for duration of response
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chadi Nabhan, MD
Organization: Oncology Specialists, S.C.
Phone: 847-268-8200
EMail: cnabhan@oncmed.net
Layout table for additonal information
Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00145418     History of Changes
Obsolete Identifiers: NCT00393081
Other Study ID Numbers: OX-03-137 (0409)
First Submitted: September 1, 2005
First Posted: September 5, 2005
Results First Submitted: July 20, 2011
Results First Posted: January 31, 2013
Last Update Posted: June 30, 2014