Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00269152

First received: December 21, 2005

Last updated: December 6, 2011

Last verified: December 2011

History of Changes

Results First Received: November 12, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-Small Cell Lung Cancer
Interventions:	Drug: pemetrexed Drug: cisplatin Drug: carboplatin

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed + Cisplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Pemetrexed + Carboplatin	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
Total	Total of all reporting groups

Baseline Measures

	Pemetrexed + Cisplatin	Pemetrexed + Carboplatin	Total
Number of Participants [units: participants]	63	59	122
Age [units: years] Mean ± Standard Deviation	60.6 ± 7.7	58.9 ± 7.2	59.7 ± 7.5
Gender [units: participants]
Female	14	18	32
Male	49	41	90
Race/Ethnicity, Customized [units: participants]
Caucasian	62	58	120
African	1	1	2
Region of Enrollment [units: participants]
France	12	8	20
Spain	7	8	15
Germany	44	43	87
Curative Surgery Used [units: participants]
Pneumonectomy	9	9	18
Lobectomy	46	46	92
Bi-lobectomy	8	4	12
Smoking History [units: participants]
Yes	56	56	112
No	7	3	10
Stage of Disease Prior to Tumor Resection ^[1] [units: participants]
Stage Ia	0	1	1
Stage Ib	27	26	53
Stage IIa	6	5	11
Stage IIb	30	25	55
Stage IIIa	0	1	1
Unknown: could have been either Stage IIIb or IV	0	1	1
Tumor Type at Initial Pathological Diagnosis [units: participants]
Adenocarcinoma of the Lung	27	23	50
Squamous Carcinoma of the Lung	24	20	44
Non-Small Cell Lung Cancer	5	4	9
Mixed Cell (Squamous/Adeno) Carcinoma of Lung	0	5	5
Large Cell Carcinoma of Lung	5	7	12
Bronchoalveolar Carcinoma	2	0	2

[1]	Classification based on the American Joint Committee on Cancer Staging Criteria for Lung Cancer.

Outcome Measures

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1. Primary:

The Feasibility of Post-Surgery Chemotherapy [ Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion ]

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2. Secondary:

Grade III/IV Adverse Events [ Time Frame: every 21-day cycle for 4 cycles ]

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3. Secondary:

Overall Survival at 3 Years [ Time Frame: baseline to date of death from any cause, assessed at 3 years ]

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4. Secondary:

3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years [ Time Frame: length of time disease free, assessed at 3 years ]

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5. Secondary:

Overall Survival at 6 Years [ Time Frame: baseline to date of death from any cause, assessed up to 6 years after the last participant was randomized ]

Results not yet posted. Anticipated Posting Date: 07/2014 Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A protocol amendment was approved after the trial original completed to allow for collection of additional overall survival data due to number of participants surviving at 3 years.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00269152 History of Changes
Other Study ID Numbers:	10105, H3E-SB-S089
Study First Received:	December 21, 2005
Results First Received:	November 12, 2008
Last Updated:	December 6, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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