Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer (TOP0602)
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| ClinicalTrials.gov Identifier: NCT00509366 |
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Recruitment Status :
Terminated
(Study terminated due to reproducibility issues with genomics prediction model.)
First Posted : July 31, 2007
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
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Sponsor:
Duke University
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Duke University
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Non Small Cell Lung Cancer |
| Interventions |
Drug: Cisplatin & Gemcitabine Drug: Cisplatin & Pemetrexed Drug: Docetaxel & Gemcitabine Drug: Pemetrexed & Gemcitabine |
| Enrollment | 101 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Cisplatin + Gemcitabine | Cisplatin + Pemetrexed | Pemetrexed + Gemcitabine | Docetaxel + Gemcitabine | Screen Failure |
|---|---|---|---|---|---|
 Arm/Group Description |
Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure. | Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure. | Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure. | Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology. | Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures. |
| Period Title: Overall Study | |||||
| Started | 18 [1] | 8 [2] | 22 [3] | 2 [4] | 51 [5] |
| Assigned Treatment | 18 [6] | 8 [7] | 22 [8] | 2 [9] | 0 |
| Completed | 17 [10] | 7 [11] | 21 [12] | 2 [13] | 51 [14] |
| Not Completed | 1 | 1 | 1 | 0 | 0 |
| Reason Not Completed | |||||
| Not Treated (Screen Failure) | 1 | 1 | 1 | 0 | 0 |
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[1]
Registered patients who were assigned cisplatin/gemcitabine treatment.
[2]
Registered patients who were assigned cisplatin/pemetrexed treatment.
[3]
Registered patients who were assigned pemetrexed/gemcitabine treatment.
[4]
Registered patients who were assigned docetaxel/gemcitabine treatment.
[5]
Registered patients who were neither assigned nor treated with protocol-based therapy.
[6]
Patients who were assigned to cisplatin/gemcitabine treatment arm.
[7]
Patients who were assigned to cisplatin/pemetrexed treatment arm.
[8]
Patients who were assigned to pemetrexed/gemcitabine treatment arm.
[9]
Patients who were assigned to docetaxel/gemcitabine treatment arm.
[10]
Patients assigned to treatment and treated with cisplatin/gemcitabine treatment combination.
[11]
Patients assigned to treatment and treated with cisplatin/pemetrexed treatment combination.
[12]
Patients assigned to treatment and treated with pemetrexed/gemcitabine treatment combination.
[13]
Patients assigned to treatment and treated with docetaxel/gemcitabine treatment combination.
[14]
Patients who were neither assigned nor treated with protocol-based therapy.
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Baseline Characteristics
| Arm/Group Title | Cisplatin + Gemcitabine | Cisplatin + Pemetrexed | Pemetrexed + Gemcitabine | Docetaxel + Gemcitabine | Screen Failure | Total | |
|---|---|---|---|---|---|---|---|
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Arm/Group Description |
Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study. | Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study. | Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study. | Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study. | Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 17 | 7 | 21 | 2 | 54 | 101 | |
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Baseline Analysis Population Description |
The number of participants in each group reflects the number of participants at the end of the study period (COMPLETED) in the Participant Flow Analysis, with the exception of 3 patients who were assigned treatment, but not treated, and were added to the number of screen failures.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 17 participants | 7 participants | 21 participants | 2 participants | 54 participants | 101 participants | |
| 62.53 (6.51) | 61.43 (9.78) | 62.14 (9.72) | 59.00 (7.07) | 61.24 (10.10) | 61.61 (9.29) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | 7 participants | 21 participants | 2 participants | 54 participants | 101 participants | |
| Female |
6 35.3%
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5 71.4%
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9 42.9%
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0 0.0%
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20 37.0%
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40 39.6%
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| Male |
11 64.7%
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2 28.6%
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12 57.1%
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2 100.0%
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34 63.0%
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61 60.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 17 participants | 7 participants | 21 participants | 2 participants | 54 participants | 101 participants |
| 17 | 7 | 21 | 2 | 54 | 101 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
The microarray-based prediction model of chemotherapy sensitivity, used to allocate patients into the cisplatin treatment arms, was irreproducible and inaccurate. Quality of life measurements were incomplete and could not be analyzed.
More Information
Results Point of Contact
| Name/Title: | Neal Ready, MD, PhD |
| Organization: | Duke University |
| Phone: | 919-681-6932 |
| EMail: | neal.ready@duke.edu |
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00509366 |
| Other Study ID Numbers: |
Pro00004599 |
| First Submitted: | July 30, 2007 |
| First Posted: | July 31, 2007 |
| Results First Submitted: | May 7, 2014 |
| Results First Posted: | August 28, 2014 |
| Last Update Posted: | August 28, 2014 |