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Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma

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ClinicalTrials.gov Identifier: NCT00256321
Recruitment Status : Terminated (Closed due to poor accrual)
First Posted : November 21, 2005
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE November 18, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date February 8, 2019
Study Start Date  ICMJE October 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Response rate of patients with gastric/gastroesophageal carcinoma when treated with celecoxib, oxaliplatin, and capcetabine combination therapy [ Time Frame: 18 weeks ]
    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
  • Determine time to progression [ Time Frame: 18 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
Define response rates and time to progression
Change History Complete list of historical versions of study NCT00256321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Incidence of treatment-related study adverse events and toxicity according to NCI Common Toxicity Criteria v2.X [ Time Frame: 18 weeks ]
    Toxicity and adverse events are graded on CTC (NCI Common Toxicity Criteria) version 2.X.
  • Evaluate the expression of the Cox-2 on paraffin-embedded tumor sections from patients enrolled on the study and correlate expression with clinical response [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
Study adverse effects/safety profile of combination chemotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma
Official Title  ICMJE A Phase II Study of Celecoxib/Oxaliplatin/Capecitabine Combination Chemotherapy for Unresectable,Recurrent, or Metastatic Gastric/Gastroesophageal Junction Carcinoma
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Carcinoma
  • Gastroesophageal Junction Carcinoma
Intervention  ICMJE
  • Drug: Oxaliplatin
    Oxaliplatin 70mg/m2 IV on Days 1 and 8
    Other Name: Eloxatin
  • Drug: Capecitabine
    Capecitabine 1000mg/m2 PO BID from Days 1 through 14.
    Other Name: Xeloda
  • Drug: Celecoxib
    Celecoxib 400mg PO BID from Days 1 through 21.
    Other Name: Celebrex
Study Arms  ICMJE Experimental: Celecoxib/Oxaliplatin/Capecitabine

Oxaliplatin 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.

Interventions:
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Drug: Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2019)
4
Original Enrollment  ICMJE
 (submitted: November 18, 2005)
20
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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
  • 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]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256321
Other Study ID Numbers  ICMJE UCI 03-34
2003-3414 ( Other Identifier: University of California, Irvine )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chao Family Comprehensive Cancer Center, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Sanofi-Synthelabo
Investigators  ICMJE
Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
PRS Account University of California, Irvine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP