Stomach NeoplasmsPhase 1NCT00555672
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
A Phase 1 study testing 5-fluorouracil, cisplatin and sunitinib malate in people with Stomach Neoplasms, run by Pfizer at 3 sites in Spain.
Trial summary
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer. 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?
- 5-fluorouracil, cisplatin and sunitinib malate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesSpain
- Study dates
- Aug 2008to Aug 2010
- Phase
- Phase 1
- 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
- confirmed diagnosis of stomach cancer
- advanced stomach cancer stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and to sign an informed consent document
Who cannot join
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041
About this study
Official title: A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- 5-fluorouracil, cisplatin, sunitinib malate
- 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
5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatinDrug
Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malateDrug
sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: 5-fluorouracil; Drug: cisplatin; Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
The incidence of DLTs assessed during the first cycle (21 days).
Measured: Cycle 1 (Baseline to Day 21)
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]
Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).
Measured: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
Measured: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Steady State Concentration (Css) of 5-Fluorouracil (5-FU)
Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Measured: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Infusion Rate (Zero Order) (R0) of 5-FU
Infusion rate of 5-FU equals total dose divided by infusion time.
Measured: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Clearance (CLss) of 5-FU
Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).
Measured: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU
Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Measured: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Number of Participants With Objective Response
Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Baseline, Day 21 of every even-numbered cycle up to 15 Months
Duration of Response (DR)
Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.
Measured: Baseline up to Month 15
Progression-Free Survival (PFS)
Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.
Measured: Baseline up to Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionAug 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.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555672
- Sponsor's protocol ID
- A6181128
- Status last verified
- Dec 2011
- First submitted
- 8 Nov 2007
- Last updated
- 19 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00555672
- Acronym / sponsor ID
- A6181128
- Conditions
- Stomach Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Posted 5 Jan 2011
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 determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 5-fluorouracil, Drug: cisplatin, Drug: sunitinib malate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed diagnosis of stomach cancer
- advanced stomach cancer stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and to sign an informed consent document
Key exclusion criteria (3 listed)
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
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-fluorouracil5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. | Drug | A |
| cisplatinCisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. | Drug | A |
| sunitinib malatesunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. | Drug | A |
Primary outcome
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Baseline to Day 21)
The incidence of DLTs assessed during the first cycle (21 days).
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]
Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Steady State Concentration (Css) of 5-Fluorouracil (5-FU)
Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Infusion Rate (Zero Order) (R0) of 5-FU
Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Clearance (CLss) of 5-FU
Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU
Time frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Number of Participants With Objective Response
Time frame: Baseline, Day 21 of every even-numbered cycle up to 15 Months
Duration of Response (DR)
Time frame: Baseline up to Month 15
Progression-Free Survival (PFS)
Time frame: Baseline up to Month 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5-fluorouracil, cisplatin and sunitinib malate in people with Stomach Neoplasms, run by Pfizer at 3 sites in Spain.
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 4 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Jan 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?
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (Baseline to Day 21)). 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 19 Dec 2011.