A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00190671

First received: September 12, 2005

Last updated: November 17, 2009

Last verified: November 2009

History of Changes

Results First Received: March 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: pemetrexed Drug: cyclophosphamide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a Phase 1/2 study. Phase 1 determined the doses to use in the Phase 2 portion. In this 2-stage Simon's optimal design study, enrollment in the 600 mg/m2 arm was stopped at the end of Stage 1 because of lack of efficacy; ongoing patients were allowed to continue treatment. Secondary efficacy endpoints were evaluated for 1800 mg/m2 arm only.

Reporting Groups

	Description
Pemetrexed 600mg/m2	Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
Pemetrexed 1800mg/m2	Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles

Participant Flow: Overall Study

	Pemetrexed 600mg/m2	Pemetrexed 1800mg/m2
STARTED	42	61
COMPLETED	15	19
NOT COMPLETED	27	42
Satisfactory Response	4	7
Lack of Efficacy	19	24
Death from Study Disease	1	1
Adverse Event	3	2
Clinical Relapse	0	1
Death from Study-Drug Toxicity	0	2
Death from Other Causes	0	2
Protocol Violation	0	1
Withdrawal by Subject	0	2

Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed 600mg/m2	Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
Pemetrexed 1800mg/m2	Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
Total	Total of all reporting groups

Baseline Measures

	Pemetrexed 600mg/m2	Pemetrexed 1800mg/m2	Total
Number of Participants [units: participants]	42	61	103
Age [units: years] Median ( Full Range )	59.0 ( 35 to 80 )	56.0 ( 32 to 81 )	58.0 ( 32 to 81 )
Gender [units: participants]
Female	42	61	103
Male	0	0	0
Region of Enrollment [units: participants]
Hungary	11	11	22
Czech Republic	2	2	4
Poland	9	11	20
Romania	9	9	18
Austria	3	11	14
Russian Federation	8	17	25
Estrogen-Receptor Status [units: participants]
Positive	22	27	49
Negative	10	21	31
Unknown	7	4	11
Missing	3	9	12
Human Epidermal Growth Factor Receptor 2 (HER-2/NEU) Status [units: participants]
Positive	4	3	7
Negative	11	27	38
Unknown	9	8	17
Not Done	18	23	41
Pathological Diagnosis [units: participant]
Inflammatory Breast Carcinoma	7	10	17
Adenocarcinoma of the Breast	17	27	44
Other	18	24	42
Progesterone-Receptor Status [units: participants]
Positive	19	25	44
Negative	13	23	36
Unknown	7	4	11
Missing	3	9	12
Race/Ethnicity [units: participants]
Caucasian	42	61	103
World Health Organization Performance Status [units: participants]
0 - Asymptomatic, fully active	18	40	58
1 - Symptomatic, fully ambulatory, light activity	22	18	40
2 - Symptomatic, ambulatory, no work activities	2	3	5
Body Surface Area [units: square meters] Median ( Full Range )	1.8 ( 1.4 to 2.1 )	1.7 ( 1.4 to 2.4 )	1.7 ( 1.4 to 2.4 )
Height [units: centimeters] Median ( Full Range )	160.0 ( 148 to 176 )	160.0 ( 143 to 180 )	160.0 ( 143 to 180 )
Weight [units: kilograms] Median ( Full Range )	71.5 ( 50 to 104 )	70.0 ( 45 to 120 )	70.0 ( 45 to 120 )

Outcome Measures

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1. Primary:

Best Tumor Response [ Time Frame: baseline to measured progressive disease ]

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2. Secondary:

Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]

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3. Secondary:

Progression Free Survival [ Time Frame: baseline to measured progressive disease ]

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4. Secondary:

Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]

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5. Secondary:

Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]

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6. Secondary:

Pharmacokinetics - Clearance (CL) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]

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7. Secondary:

Pharmacokinetics - Volume of Distribution [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]

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8. Secondary:

Pharmacokinetics - Half-Life (t½) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]

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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
600 mg/m2 arm discontinued at end of Phase 1 because of lack of efficacy. Enrollment in 1800 mg/m2 arm continued to Phase 2. (Phase 1 outcomes were tumor response and pharmacokinetics). Secondary efficacy endpoints analyzed for 1800 mg/m2 arm only.

Results Point of Contact:

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

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00190671 History of Changes
Other Study ID Numbers:	4029, H3E-MC-JMDV
Study First Received:	September 12, 2005
Results First Received:	March 17, 2009
Last Updated:	November 17, 2009
Health Authority:	United States: Food and Drug Administration

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