Gastric CancerPhase 2NCT00354224
Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
A Phase 2 study testing capecitabine and oxaliplatin in people with Gastric Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- capecitabine and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed gastric cancer
- Locally advanced, unresectable, or metastatic disease
- Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during study and for 6 months after completion of study treatment
- Able to swallow
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluoropyrimidines or platinum chemotherapy agents
- No uncontrolled intercurrent illness including, but not limited to the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- At least 6 months since prior radiotherapy with capecitabine as a radioenhancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent chemotherapy
- No concurrent palliative radiotherapy
- No concurrent hormonal therapy except for the following:
- Steroids for adrenal failure
- Hormones for nondisease related conditions (e.g., insulin for diabetes)
- Intermittent use of dexamethasone as an antiemetic
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.
Secondary
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
- Conditions
- Gastric Cancer
- Being tested
- capecitabine, oxaliplatin
- Keywords
- recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin + Capecitabine | Experimental | Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. Receives: Drug: capecitabine; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate as Determined by RECIST.
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Every 6 weeks through study completion for up to about 18 weeks
Secondary outcomes (2)
Number of Adverse Events
Measured: From the start of study treatment through study completion for up to about 18 weeks
Progression-free Survival
Measured: Every 6 weeks through study completion for up to about 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: due to low accrual
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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzair B. Chaudhary, MD, Study chair, Medical University of South CarolinaGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354224
- Sponsor's protocol ID
- MUSC-100829
- Other IDs
- MUSC-OX-33-064, MUSC-HR-11497, CDR0000484638
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2006
- Last updated
- 16 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00354224
- Acronym / sponsor ID
- MUSC-100829
- Conditions
- Gastric Cancer
- Keywords
- recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to low accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 16 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.
Secondary
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin + Capecitabine | Experimental | Drug: capecitabine, Drug: oxaliplatinPatients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabine | Drug | Oxaliplatin + Capecitabine |
| oxaliplatin | Drug | Oxaliplatin + Capecitabine |
Primary outcome
Response Rate as Determined by RECIST.
Time frame: Every 6 weeks through study completion for up to about 18 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
2 secondary outcomes
Number of Adverse Events
Time frame: From the start of study treatment through study completion for up to about 18 weeks
Progression-free Survival
Time frame: Every 6 weeks through study completion for up to about 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Uzair B. Chaudhary, MD study chair
Medical University of South Carolina
Gustavo Leone study chair
Medical University of South Carolina, Hollings Cancer Center
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 capecitabine and oxaliplatin in people with Gastric Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Jul 2018. 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 United States. 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 16 Jul 2018). 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?
Response Rate as Determined by RECIST. (time frame: Every 6 weeks through study completion for up to about 18 weeks). 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 16 Jul 2018.