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Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00487669
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Non-small Cell Lung Cancer
Intervention Drug: paclitaxel poliglumex, pemetrexed
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paclitaxel Poliglumex With Pemetrexed
Hide Arm/Group Description The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Paclitaxel Poliglumex With Pemetrexed
Hide Arm/Group Description The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  58.3%
>=65 years
5
  41.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.
Hide Description [Not Specified]
Time Frame CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Level 1 Level 2
Hide Arm/Group Description:
The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Stable Disease 5 4
Progressive Disease 1 2
2.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame time from study entry until the first documented sign of progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Level 1 Level 2
Hide Arm/Group Description:
The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: months
3.8
(1.5 to 9.2)
2.8
(0.7 to 10.5)
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame time from study entry until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Level 1 Level 2
Hide Arm/Group Description:
The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(3.7 to 21.4)
8.5
(2.4 to 22.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Level 1 Level 2
Hide Arm/Group Description The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks. Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
All-Cause Mortality
Level 1 Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Level 1 Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   5/6 (83.33%) 
Blood and lymphatic system disorders     
Neutropenia Grade 3  0/6 (0.00%)  2/6 (33.33%) 
Neutropenia Grade 4  0/6 (0.00%)  1/6 (16.67%) 
General disorders     
Fatigue Grade 3  0/6 (0.00%)  2/6 (33.33%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Level 1 Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
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: James Rigas, MD
Organization: Dartmouth-Hitchcock Medical Center
Phone: 603-650-6344
EMail: james.r.rigas@hitchcock.org
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00487669    
Other Study ID Numbers: D-0433
First Submitted: June 14, 2007
First Posted: June 18, 2007
Results First Submitted: November 21, 2013
Results First Posted: January 9, 2014
Last Update Posted: January 9, 2014