Stomach NeoplasmsPhase 2NCT00382720
Docetaxel and Oxaliplatin in Gastric Cancer
A Phase 2 study testing Docetaxel + Oxaliplatin, Docetaxel + Oxaliplatin + 5-FU and Docetaxel + Oxaliplatin + Capecitabine in people with Stomach Neoplasms, run by Sanofi at 12 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Docetaxel + Oxaliplatin, Docetaxel + Oxaliplatin + 5-FU and Docetaxel + Oxaliplatin + Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Sep 2006to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
- Metastatic or locally recurrent disease
- Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed > 12 months after the end of the chemotherapy
- Performance status Karnofsky index > 70
- Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L
- Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL < creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)
- Measurable and/or evaluable metastatic disease
Who cannot join
- Any prior palliative chemotherapy
- Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: A Randomized Phase II Study 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
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:
Read more
- 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)
Read the 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.
- Conditions
- Stomach Neoplasms
- Being tested
- Docetaxel + Oxaliplatin, Docetaxel + Oxaliplatin + 5-FU, Docetaxel + Oxaliplatin + Capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + OxaliplatinDrug
Dose level 1 (non-optimal dose):
Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1
Dose level 2 (optimal dose):
Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1
Docetaxel + Oxaliplatin + 5-FUDrug
Dose level 1 (non-optimal dose):
Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 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.
Dose level 2 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 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.
Docetaxel + Oxaliplatin + CapecitabineDrug
Dose level 1 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.
Dose level 2 (non-optimal dose):
Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously.
| Study group | Role | What they receive |
|---|---|---|
| TE (Taxotere and Eloxatin) | Experimental | 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. Receives: Drug: Docetaxel + Oxaliplatin |
| TEF (Taxotere, Eloxatin and 5-FU) | Experimental | 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. Receives: Drug: Docetaxel + Oxaliplatin + 5-FU |
| TEX (Taxotere, Eloxatin and Xeloda) | Experimental | 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. Receives: Drug: Docetaxel + Oxaliplatin + Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
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.
Measured: every 8 weeks up to a maximum of 36 months
Secondary outcomes (2)
Best Overall Response Rate (ORR)
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.
Measured: every 8 weeks up to a maximum of 36 months
Overall Survival (OS)
The number of months measured from the date of randomization to the date of death due to any cause.
Measured: up to a maximum of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382720
- Sponsor's protocol ID
- DOCOX_C_00082
- Other IDs
- EudraCT # : 2005-005464-92
- Status last verified
- Dec 2012
- First submitted
- 27 Sep 2006
- Last updated
- 7 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496.
PubMed 25416687
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study 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
- ClinicalTrials.gov ID
- NCT00382720
- Acronym / sponsor ID
- DOCOX_C_00082
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Posted 10 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TE (Taxotere and Eloxatin) | Experimental | Drug: Docetaxel + OxaliplatinDocetaxel (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) | Experimental | Drug: Docetaxel + Oxaliplatin + 5-FUDocetaxel (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. |
| TEX (Taxotere, Eloxatin and Xeloda) | Experimental | Drug: Docetaxel + Oxaliplatin + CapecitabineDocetaxel (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
- Metastatic or locally recurrent disease
- Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed > 12 months after the end of the chemotherapy
- Performance status Karnofsky index > 70
- Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L
Key exclusion criteria (3 listed)
- Any prior palliative chemotherapy
- Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel + OxaliplatinDose level 1 (non-optimal dose): Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1 Dose level 2 (optimal dose): Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1 | Drug | TE (Taxotere and Eloxatin) |
| Docetaxel + Oxaliplatin + 5-FUDose level 1 (non-optimal dose): Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 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. Dose level 2 (optimal dose): Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 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. | Drug | TEF (Taxotere, Eloxatin and 5-FU) |
| Docetaxel + Oxaliplatin + CapecitabineDose level 1 (optimal dose): Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously. Dose level 2 (non-optimal dose): Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously. | Drug | TEX (Taxotere, Eloxatin and Xeloda) |
Primary outcome
Time to Progression
Time frame: 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.
2 secondary outcomes
Best Overall Response Rate (ORR)
Time frame: every 8 weeks up to a maximum of 36 months
Overall Survival (OS)
Time frame: up to a maximum of 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25416687Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Aussel study director
Sanofi
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel + Oxaliplatin, Docetaxel + Oxaliplatin + 5-FU and Docetaxel + Oxaliplatin + Capecitabine in people with Stomach Neoplasms, run by Sanofi at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium, France, Germany, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (time frame: every 8 weeks up to a maximum of 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.