Docetaxel and Oxaliplatin in Gastric Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00382720

First received: September 27, 2006

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Results First Received: April 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Stomach Neoplasms
Interventions:	Drug: Docetaxel + Oxaliplatin Drug: Docetaxel + Oxaliplatin + 5-FU Drug: Docetaxel + Oxaliplatin + Capecitabine

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
A total 275 participants from 12 countries were randomized in the part I/II study. 64 participants were enrolled in Part I. 211 new participants were enrolled specifically for Part II.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The intent-to-treat (ITT) population, included 254 participants randomized to the optimal dose of study medication from Parts I (43) and II (211), and excluded 21 participants administered the non-optimal dose in Part I.

Reporting Groups

	Description
(TE) Taxotere and Eloxatin	Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
(TEF) Taxotere, Eloxatin and 5-fluorouracil	Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
(TEX) Taxotere, Eloxatin and Xeloda	Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.

Participant Flow: Overall Study

	(TE) Taxotere and Eloxatin	(TEF) Taxotere, Eloxatin and 5-fluorouracil	(TEX) Taxotere, Eloxatin and Xeloda
STARTED	79	89	86
Administered Non-Optimal Dose (Part I)	10	11	0
Administered Optimal Dose (Parts I & II)	78	88	82
Full Analysis Population (FAP)	78 ^[1]	88 ^[1]	82 ^[1]
COMPLETED	0	0	0
NOT COMPLETED	79	89	86
Adverse Event	21	23	15
Protocol Violation	2	5	1
Death	0	1	2
Progressive disease	37	28	38
Withdrew consent	1	1	2
Withdrawal by Subject	11	20	12
Surgery	1	1	4
Patient did not receive study medication	1	1	4
Clinically progressive disease	0	1	0
Good prognosis	0	1	0
Investigator/Clinical decision	5	6	6
Discontinued at end of study	0	1	2

[1]	ITT who received at least one dose of study medication

Baseline Characteristics

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Reporting Groups

	Description
(TE) Taxotere and Eloxatin	Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
(TEF) Taxotere, Eloxatin and 5-fluorouracil	Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
(TEX) Taxotere, Eloxatin and Xeloda	Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
Total	Total of all reporting groups

Baseline Measures

	(TE) Taxotere and Eloxatin	(TEF) Taxotere, Eloxatin and 5-fluorouracil	(TEX) Taxotere, Eloxatin and Xeloda	Total
Number of Participants [units: participants]	79	89	86	254
Age [units: years] Mean ± Standard Deviation	59.2 ± 11.4	57.9 ± 11.1	59.0 ± 11.0	58.7 ± 11.1
Gender [units: participants]
Female	28	28	22	78
Male	51	61	64	176
Race/Ethnicity, Customized [units: participants]
Asian/Oriental	0	1	0	1
Black	1	0	0	1
White	77	87	84	248
Unknown or Not Reported	1	1	2	4
Karnofsky Performance Status (KPS) [units: participants]
100% Normal, no complaints: no evidence of disease	19	28	19	66
90% Able to carry on normal activity; minor signs	26	35	31	92
80% Normal activity with effort, some signs	31	24	33	88
70% Cares for self but unable to work	1	2	3	6
<70% Requires assistance	1	0	0	1
Missing	1	0	0	1
Weight loss during last 3 months [units: participants]
less than or equal to 5%	39	47	44	130
greater than 5%	39	42	41	122
Missing	1	0	1	2

Outcome Measures

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1. Primary:

Time to Progression [ Time Frame: every 8 weeks up to a maximum of 36 months ]

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2. Secondary:

Best Overall Response Rate (ORR) [ Time Frame: every 8 weeks up to a maximum of 36 months ]

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3. Secondary:

Overall Survival (OS) [ Time Frame: up to a maximum of 36 months ]

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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. Restriction Description: If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.

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: International Clinical Development Clinical Study Director
Organization: sanofi-aventis
e-mail: contact-us@sanofi-aventis.com

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00382720 History of Changes
Other Study ID Numbers:	DOCOX_C_00082, EudraCT # : 2005-005464-92
Study First Received:	September 27, 2006
Results First Received:	April 29, 2011
Last Updated:	December 19, 2012
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

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