Docetaxel and Oxaliplatin in Gastric Cancer

Phase 2

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: Docetaxel + Oxaliplatin + Capecitabine; Drug: Docetaxel + Oxaliplatin; Drug: Docetaxel + Oxaliplatin + 5-FU

• Registration Number: NCT00382720
• Lead Sponsor: Sanofi

Brief Summary

This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

* To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

* To establish the safety profile.

* To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria

* To assess the Overall Survival (OS)

Detailed Description

The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxicities, or withdrawal of consent. The reason and date of removal of all participants was documented on the case report form.

Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy. Then, they would be followed every 3 months after progression for survival status; date of death or progression were reported. Participants who ended treatment for progression, were to be followed every 3 months until death. Date of death was reported. The planned duration of the study was 30 months.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-09-29
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-29
• Results First Submitted QC: 2011-07-13
• Results First Posted: 2011-08-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEX (Taxotere, Eloxatin and Xeloda)	Docetaxel + Oxaliplatin + Capecitabine	Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study.
TE (Taxotere and Eloxatin)	Docetaxel + Oxaliplatin	Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study.
TEF (Taxotere, Eloxatin and 5-FU)	Docetaxel + Oxaliplatin + 5-FU	Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study.

Primary Outcome Measures

Name	Time	Method
Time to Progression	every 8 weeks up to a maximum of 36 months	The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.; WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.

Secondary Outcome Measures

Name	Time	Method
Best Overall Response Rate (ORR)	every 8 weeks up to a maximum of 36 months	Percentage of partial and complete responses, according to WHO criteria: Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.; Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart.
Overall Survival (OS)	up to a maximum of 36 months	The number of months measured from the date of randomization to the date of death due to any cause.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom