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

• 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: Dartmouth-Hitchcock Medical Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Paclitaxel Poliglumex With Pemetrexed
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

Baseline Characteristics

Arm/Group Title		Paclitaxel Poliglumex With Pemetrexed
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
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

Outcome Measures

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.
Description	[Not Specified]
Time Frame	CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level 1	Level 2
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
Description	[Not Specified]
Time Frame	time from study entry until the first documented sign of progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level 1	Level 2
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
Description	[Not Specified]
Time Frame	time from study entry until death

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level 1	Level 2
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Level 1	Level 2
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	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: James Rigas, MD
• Organization: Dartmouth-Hitchcock Medical Center
• Phone: 603-650-6344
• EMail: james.r.rigas@hitchcock.org

• 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