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Gastric CarcinomaPhase 2NCT00256321

Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma

A Phase 2 study testing Oxaliplatin, Capecitabine and Celecoxib in people with Gastric Carcinoma and Gastroesophageal Junction Carcinoma, run by University of California, Irvine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical resection improve the survival and the chance of cure. Unfortunately, majority of cases are diagnosed at advanced stage, with only 20% of the patients presenting with localized disease. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Oxaliplatin, Capecitabine and Celecoxib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Oct 2004to Aug 2007
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have histologically proven, pathologically verified and surgically incurable(unresectable, recurrent, or metastatic) gastric/gastroesophageal junction carcinoma. Gastric lymphoma and Gastrointestinal stromal tumor(GIST) are ineligible for this study. At least 6 unstained paraffin-embedded pathologic specimen slides will be required for the COX-2 expression assays.
  • Patient must have bidimensionally measurable disease as defined below. Measurable lesions must be assessed (by physical examination, CT scan, radionuclide scan or plain X-ray) within 30 days prior to registration. The patient's disease status must be completely assessed and reported.
  • (Measurable Disease: Bidimensionally measurable lesions with clearly defined margins by: 1) Ruler measurement or medical photograph (skin or oral lesion), or plain x ray with at least one diameter .5 cm or greater (bone lesions are not included) or, 2) CT, MRI or other imaging scan with both diameters greater than the distance between cuts of the imaging study, or 3) palpation with both diameters 2 cm or greater.)
  • All patients must undergo a CT of abdomen and chest within 30 days prior to registration.
  • Patients may have received prior radiation therapy. Radiation therapy must have been completed at least 30 days before registration.
  • Patients may have received prior surgery. Prior surgery must have been completed at least 30 days before registration.
  • Performance status must be 0-2 according to Southwest Oncology Group Criteria

Who cannot join

  • Patients with brain metastases are NOT eligible for this study. It is not mandatory to obtain brain CT or MRI on all patients. However, patients who exhibit neurological symptoms or have pulmonary metastases on radiographic studies must obtain brain CT w/ IV contrast or MRI prior to registration to ascertain the presence of brain metastasis.
  • Patients must NOT have received capecitabine or oxaliplatin. Prior use of cisplatin, carboplatin, 5-FU are permitted. Prior systemic therapy must have been completed at least 30 days before registration.
  • Pregnant or nursing women are not eligible to participate in this trial because the safe use of these drugs in pregnancy have not been established. Urine pregnancy test must be done prior to the study.
  • Patient must NOT have known allergic reaction to sulfonamides
  • Patient must NOT have known allergic or other adverse reaction to celecoxib
  • Patient must NOT have persistent peripheral neuropathy
Show all 9Show fewer
  • Patient must NOT have known hypersensitivity reactions to 5-FU or platinum
  • Patient must NOT have active gastric/duodenal bleeding
  • Patient must NOT have had a sensitivity reaction to aspirin or other NSAIDS nonsteroidal antiinflammatory drugs (NSAIDS) [experiencing asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs]

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Phase II Study of Celecoxib/Oxaliplatin/Capecitabine Combination Chemotherapy for Unresectable,Recurrent, or Metastatic Gastric/Gastroesophageal Junction Carcinoma

Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical resection improve the survival and the chance of cure. Unfortunately, majority of cases are diagnosed at advanced stage, with only 20% of the patients presenting with localized disease. The five-year survival for gastric cancer of all stages remains at a dismal 8%. Chemotherapy has been used for advanced gastric cancer but with unsatisfactory results. Therefore, new approaches are needed for these patients. Among the newer chemotherapy regimens for advanced gastric cancer include a combination of oral 5-Fluoro-Uracil (FU)-based compound called Capecitabine(Xeloda) and Oxaliplatin. A few phase II studies suggest that the combination regimen is active with overall response rates ranging 30-40%. Several preclinical and clinical studies have shown that the expression of cyclooxygenase enzyme II(COX-2) is upregulated in many pre-neoplastic and neoplastic lesions. Furthermore, there appears to be an association with the overexpression of Cox-2 and the invasiveness of cancer and prognosis. Finally, preclinical and clinical studies suggest selective Cox-2 inhibitors can induce apoptosis in gastric cancer cells and retard tumor progression. Therefore, there is a strong rationale for the combination of a selective Cox-2 inhibitor, Celecoxib, with Capecitabine and Oxaliplatin in a therapeutic phase II trial for patients with advanced or recurrent gastric cancer.

Keywords
Gastric Carcinoma, Gastroesophageal junction Carcinoma
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin 70mg/m2 IV on Days 1 and 8

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000mg/m2 PO BID from Days 1 through 14.

  • CelecoxibDrug

    Also called Celebrex

    Celecoxib 400mg PO BID from Days 1 through 21.

Study groups in NCT00256321
Study groupRoleWhat they receive
Celecoxib/Oxaliplatin/CapecitabineExperimentalOxaliplatin 70mg/m2 IV on Days 1 and 8. Capecitabine 1000mg/m2 PO BID from Days 1 through 14. Celecoxib 400mg PO BID from Days 1 through 21. 1 Cycle = 21 days.
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of patients with gastric/gastroesophageal carcinoma when treated with celecoxib, oxaliplatin, and capcetabine combination therapy

    Complete Response (CR) Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of non evaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable and non evaluable lesions and sites must be assessed using the same techniques as baseline.

    Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.

    A response rate (RR) is defined as a complete or partial response. RR=CR+PR

    Measured: 18 weeks

  2. Determine time to progression

    Progression: 50% increase or an increase of 10 CM2 (whichever is smaller) in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion which had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). For "scan only" bone disease, increased uptake does not constitute clear worsening. Worsening of existing non evaluable disease does not constitute progression.

    Measured: 18 weeks

Secondary outcomes (2)

  1. Incidence of treatment-related study adverse events and toxicity according to NCI Common Toxicity Criteria v2.X

    Toxicity and adverse events are graded on CTC (NCI Common Toxicity Criteria) version 2.X.

    Measured: 18 weeks

  2. Evaluate the expression of the Cox-2 on paraffin-embedded tumor sections from patients enrolled on the study and correlate expression with clinical response

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionAug 2007
  4. Study completionAug 2007

Why it stopped: Closed due to poor accrual

Resources

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00256321
Sponsor's protocol ID
UCI 03-34
Other IDs
2003-3414
Status last verified
Feb 2019
First submitted
18 Nov 2005
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Capecitabine and Celecoxib in people with Gastric Carcinoma and Gastroesophageal Junction Carcinoma, run by University of California, Irvine 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?

The sponsor lists 7 inclusion and 9 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 8 Feb 2019. 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?

The study was stopped early (reason given: Closed due to poor accrual). 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 of patients with gastric/gastroesophageal carcinoma when treated with celecoxib, oxaliplatin, and capcetabine combination therapy (time frame: 18 weeks). The study lists 2 primary outcomes in all. 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 NCT00256321.

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 8 Feb 2019.

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