Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00334802

First received: June 6, 2006

Last updated: March 10, 2010

Last verified: March 2010

History of Changes

Results First Received: May 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metastatic Breast Cancer
Interventions:	Drug: gemcitabine Drug: paclitaxel

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
No text entered.

Reporting Groups

	Description
Dose Level 1	Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Dose Level 2	Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles

Participant Flow: Overall Study

	Dose Level 1	Dose Level 2
STARTED	6	56
COMPLETED	0	16
NOT COMPLETED	6	40
Progressive Disease	2	24
Toxicity	1	5
Lack of Efficacy	1	3
Patient Condition Aggrevated	1	0
Physician Decision	1	0
Withdrawal by Subject	0	4
Adverse Event	0	3
Criteria for Starting Next Cycle Not Met	0	1

Baseline Characteristics

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Reporting Groups

	Description
Dose Level 1	Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Dose Level 2	Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Total	Total of all reporting groups

Baseline Measures

	Dose Level 1	Dose Level 2	Total
Number of Participants [units: participants]	6	56	62
Age [units: years] Mean ± Standard Deviation	58.2 ± 4.49	54.4 ± 8.73	54.7 ± 8.46
Gender [units: participants]
Female	6	56	62
Male	0	0	0
Region of Enrollment [units: participants]
Japan	6	56	62
Age at Primary Diagnosis [units: participants]
<30 years old	0	0	0
30 to <40 years old	0	3	3
40 to <50 years old	1	20	21
50 to <60 years old	3	24	27
60 to <70 years old	2	8	10
≥70 years old	0	1	1
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] [units: participants]
0 - Fully Active	4	50	54
1 - Ambulatory, Restricted Strenuous Activity	2	6	8
Body Weight [units: kilograms] Mean ± Standard Deviation	57.18 ± 15.313	55.76 ± 8.715	55.90 ± 9.375
Height [units: centimeters] Mean ± Standard Deviation	153.53 ± 7.987	154.71 ± 6.184	154.60 ± 6.312

[1]	Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Outcome Measures

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1. Primary:

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

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2. Secondary:

Duration of Response [ Time Frame: time of response to progressive disease ]

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3. Secondary:

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

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4. Secondary:

Number of Participants Alive at One Year (1-Year Survival) [ Time Frame: baseline to date of death from any cause, evaluated at 1 year ]

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5. Secondary:

Pharmacokinetics - Maximum Plasma Concentration (Cmax) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ]

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6. Secondary:

Pharmacokinetics - Area Under the Concentration Curve (AUC) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ]

Show Outcome Measure 6

7. Secondary:

Pharmacokinetics - Half Life (t½) [ Time Frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) ]

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Measure Type	Secondary
Measure Title	Pharmacokinetics - Half Life (t½)
Measure Description	Apparent elimination half-life.
Time Frame	cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.

Reporting Groups

	Description
Gemcitabine + Paclitaxcel	Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
Gemcitabine	Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8

Measured Values

	Gemcitabine + Paclitaxcel	Gemcitabine
Number of Participants Analyzed [units: participants]	12	12
Pharmacokinetics - Half Life (t½) [units: hours] Geometric Mean ( Full Range )	0.282 ( 0.192 to 1.00 )	0.258 ( 0.162 to 0.969 )

No statistical analysis provided for Pharmacokinetics - Half Life (t½)

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00334802 History of Changes
Other Study ID Numbers:	9066, B9E-JE-MB22
Study First Received:	June 6, 2006
Results First Received:	May 29, 2009
Last Updated:	March 10, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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