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Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256321
First received: November 18, 2005
Last updated: February 27, 2008
Last verified: February 2008
History of Changes

November 18, 2005
February 27, 2008
October 2004
Not Provided
Define response rates and time to progression
Same as current
Complete list of historical versions of study NCT00256321 on ClinicalTrials.gov Archive Site
Study adverse effects/safety profile of combination chemotherapy
Same as current
Not Provided
Not Provided
 
Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma
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 5FU-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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Carcinoma
  • Gastroesophageal Junction Carcinoma
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Drug: Celecoxib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
Not Provided

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 in Section 10.1a. All 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.
  • All patients must undergo a CT of abdomen and chest within 30 days prior to registration.
  • 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.
  • 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.
  • Patients must have a Zubrod Performance Status of 0-2.
  • 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 [experiencing asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs]
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00256321
UCI 03-34
Not Provided
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University of California, Irvine
Not Provided
Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
University of California, Irvine
February 2008

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