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Trial record 24 of 24 for:    "Adenosquamous Lung Carcinoma" | "Antineoplastic Agents, Phytogenic"

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00863512
Recruitment Status : Terminated
First Posted : March 18, 2009
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Drug: vinorelbine tartrate
Procedure: standard follow-up care
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Chemotherapy) Arm II (Observation)
Hide Arm/Group Description Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive standard care (observation).
Period Title: Overall Study
Started 17 17
Completed 3 17
Not Completed 14 0
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             11             0
Physician Decision             1             0
Arm/Group Title Arm I (Chemotherapy) Arm II (Observation) Total
Hide Arm/Group Description Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive standard care (observation). Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
67
(43 to 78)
63
(49 to 77)
67
(43 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
10
  58.8%
19
  55.9%
Male
8
  47.1%
7
  41.2%
15
  44.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.9%
1
   2.9%
Black or African American
2
  11.8%
1
   5.9%
3
   8.8%
White
15
  88.2%
15
  88.2%
30
  88.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Up to 12 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection.
Arm/Group Title Arm I (Chemotherapy) Arm II (Observation)
Hide Arm/Group Description:
Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive standard care (observation).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Data is available on 8 participants recruited to Arm I. Adverse event reporting was not required, per protocol, for participants on Arm II (observation); therefore, there are no adverse event data to report for this arm.
 
Arm/Group Title Arm II (Observation) Arm I (Chemotherapy)
Hide Arm/Group Description Patients receive standard care (observation). Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm II (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm II (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      2/8 (25.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/0  0 1/8 (12.50%)  1
Cardiac disorders     
Sinus tachycardia  1  0/0  0 1/8 (12.50%)  1
Eye disorders     
Eye disorders - Other, specify  1  0/0  0 1/8 (12.50%)  1
Gastrointestinal disorders     
Mucositis oral  1  0/0  0 1/8 (12.50%)  1
Nausea  1  0/0  0 1/8 (12.50%)  1
Infections and infestations     
Infections and infestations - Other, specify  1  0/0  0 1/8 (12.50%)  1
Metabolism and nutrition disorders     
Hypokalemia  1  0/0  0 1/8 (12.50%)  1
Hypophosphatemia  1  0/0  0 1/8 (12.50%)  1
Nervous system disorders     
Nervous system disorders - Other, specify  1  0/0  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  0/0  0 1/8 (12.50%)  1
Vascular disorders     
Hypertension  1  0/0  0 1/8 (12.50%)  1
Hypotension  1  0/0  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm II (Observation) Arm I (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      5/8 (62.50%)    
Ear and labyrinth disorders     
Hearing impaired  1  0/0  0 1/8 (12.50%)  5
Gastrointestinal disorders     
Mucositis oral  1  0/0  0 2/8 (25.00%)  2
Nausea  1  0/0  0 1/8 (12.50%)  5
Vomiting  1  0/0  0 1/8 (12.50%)  1
General disorders     
Fatigue  1  0/0  0 1/8 (12.50%)  1
Investigations     
Creatinine increased  1  0/0  0 1/8 (12.50%)  4
Investigations - Other, specify  1  0/0  0 1/8 (12.50%)  1
Platelet count decreased  1  0/0  0 1/8 (12.50%)  1
Metabolism and nutrition disorders     
Anorexia  1  0/0  0 3/8 (37.50%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/0  0 1/8 (12.50%)  3
Myalgia  1  0/0  0 2/8 (25.00%)  2
Pain in extremity  1  0/0  0 1/8 (12.50%)  1
Nervous system disorders     
Peripheral motor neuropathy  1  0/0  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/0  0 2/8 (25.00%)  5
Pleural effusion  1  0/0  0 1/8 (12.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Harpole, M.D.
Organization: Duke University Medical Center
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00863512     History of Changes
Other Study ID Numbers: CALGB-30506
CALGB-30506
CDR0000636895 ( Registry Identifier: NCI Physician Data Query )
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: December 13, 2016
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017