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
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Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
7 58.3%
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>=65 years |
5 41.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | |
Female |
6 50.0%
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Male |
6 50.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants |
12 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |