Stomach NeoplasmsPhase 3NCT00811447
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
A Phase 3 study testing 5-fluorouracil, Cisplatin and Docetaxel in people with Stomach Neoplasms, run by Sanofi at 1 site in China.
Trial summary
Primary objective: To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF]) Secondary objectives: To detect a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- 5-fluorouracil, Cisplatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion.
- Performance status Karnofsky index >70%
- Life expectancy of more than 3 months
- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
- Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value
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- Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL
- No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant therapy and first relapse.
- At least 6 weeks from prior radiotherapy and 3 weeks from surgery
- Complete initial work-up within two weeks prior to first infusion for clinical evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.
Who cannot join
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
- Other tumor type than adenocarcinoma
- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant
- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose > 300mg/m²
- Previous or current malignancies other than gastric carcinoma, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
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- Patients with known brain or leptomeningeal metastases
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria
- Other serious illness or medical conditions:
- unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or seizures
- active uncontrolled infection
- active disseminated intravascular coagulation
- other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment at low doses
- Definite contraindications for the use of corticosteroids
- Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml
- Liver impairment with AST or ALT more than 1.5UNL associated with alkaline phosphatase more than 2.5UNL
- Concurrent or within 4 week period administration of any other experimental drugs
- Concurrent treatment with any other anti-cancer therapy
- 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
1 site in 1 country.
About this study
Official title: Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Primary objective:
To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])
Secondary objectives:
- To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
- To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
- Conditions
- Stomach Neoplasms
- Being tested
- 5-fluorouracil, Cisplatin, Docetaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
600 mg/m²/day intravenous
CisplatinDrug
60 mg/m² or 75 mg/m² intravenous
DocetaxelDrug
60 mg/m² intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. Receives: Drug: 5-fluorouracil; Drug: Cisplatin; Drug: Docetaxel |
| 2 | Active comparator | Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. Receives: Drug: 5-fluorouracil; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: Throughout the study period
Secondary outcomes (5)
Safety profile
Measured: Throughout the study period
Overall survival
Measured: From beginning to end of study
Tumor response
Measured: every 8 weeks
Clinical toxicities/symptomatology
Measured: Throughout the study period
Laboratory toxicities/symptomatology
Measured: Throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Thoenes, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811447
- Sponsor's protocol ID
- DOCET_L_02195
- Status last verified
- Aug 2012
- First submitted
- 18 Dec 2008
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
- ClinicalTrials.gov ID
- NCT00811447
- Acronym / sponsor ID
- DOCET_L_02195
- Conditions
- Stomach Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])
Secondary objectives:
- To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
- To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5-fluorouracil, Drug: Cisplatin, Drug: DocetaxelAdministration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. |
| 2 | Active comparator | Drug: 5-fluorouracil, Drug: CisplatinCisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion.
- Performance status Karnofsky index >70%
- Life expectancy of more than 3 months
- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
Key exclusion criteria (21 listed)
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
- Other tumor type than adenocarcinoma
- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant
- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose > 300mg/m²
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 |
|---|---|---|
| 5-fluorouracil600 mg/m²/day intravenous | Drug | 1, 2 |
| Cisplatin60 mg/m² or 75 mg/m² intravenous | Drug | 1, 2 |
| Docetaxel60 mg/m² intravenous | Drug | 1 |
Primary outcome
Time to progression
Time frame: Throughout the study period
5 secondary outcomes
Safety profile
Time frame: Throughout the study period
Overall survival
Time frame: From beginning to end of study
Tumor response
Time frame: every 8 weeks
Clinical toxicities/symptomatology
Time frame: Throughout the study period
Laboratory toxicities/symptomatology
Time frame: Throughout the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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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.
Martin Thoenes study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-fluorouracil, Cisplatin and Docetaxel in people with Stomach Neoplasms, run by Sanofi at 1 site in China.
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 10 inclusion and 21 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Throughout the study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2012.