Gastric CancerPhase 2NCT00568971
Study of Weekly DCF to Treat Advanced Gastric Cancer
A Phase 2 study testing Docetaxel, Cisplatin, 5-Fu in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel, Cisplatin, 5-Fu
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 2
- 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
- Age between 18 and 70 years
- Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
- ECOG performance status ≤1,life expectancy more than 3 months,
- Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
- Measurable disease according to the RECIST.
Who cannot join
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Received other chemotherapy regimen after metastasis
- Used taxane in adjuvant settings
- Participated in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer
The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.
Read the detailed description
Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel, Cisplatin, 5-Fu
- Keywords
- DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity
- 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, Cisplatin, 5-FuDrug
Also called wDCF
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
| Study group | Role | What they receive |
|---|---|---|
| weekly chemo | Experimental | Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities. Receives: Drug: Docetaxel, Cisplatin, 5-Fu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate, overall survival
Measured: 2-6 months
Secondary outcomes (1)
Side effects
Measured: 2-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: The study has finished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Li, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568971
- Sponsor's protocol ID
- DCF-AGC
- Status last verified
- Aug 2009
- First submitted
- 5 Dec 2007
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00568971
- Acronym / sponsor ID
- DCF-AGC
- Conditions
- Gastric Cancer
- Keywords
- DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has finished.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Dec 2007 (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.
The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.
Detailed description
Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weekly chemo | Experimental | Drug: Docetaxel, Cisplatin, 5-FuDocetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years
- Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
- ECOG performance status ≤1,life expectancy more than 3 months,
- Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
- Measurable disease according to the RECIST.
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Received other chemotherapy regimen after metastasis
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, Cisplatin, 5-FuAlso: wDCFDocetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities. | Drug | weekly chemo |
Primary outcome
Response rate, overall survival
Time frame: 2-6 months
1 secondary outcome
Side effects
Time frame: 2-6 month
Results and safety
The study was stopped early (reason given: The study has finished.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
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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.
Jin Li, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Cisplatin, 5-Fu in people with Gastric Cancer, run by Fudan University 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Jan 2010. 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 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?
The study was stopped early (reason given: The study has finished.). Results are not available in the source record.
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?
Response rate, overall survival (time frame: 2-6 months). 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 27 Jan 2010.