Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma

Tracking Information
First Submitted Date ICMJE	November 18, 2005
First Posted Date ICMJE	November 21, 2005
Last Update Posted Date	February 29, 2008
Study Start Date ICMJE	October 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 18, 2005)	Define response rates and time to progression
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00256321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 18, 2005)	Study adverse effects/safety profile of combination chemotherapy
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE 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 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Gastric Carcinoma; Gastroesophageal Junction Carcinoma
Intervention ICMJE	Drug: Oxaliplatin; Drug: Capecitabine; Drug: Celecoxib
Study Arms	Not Provided
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	Completed
Enrollment ICMJE; (submitted: November 18, 2005)	20
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2007
Primary Completion Date	Not Provided
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 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]
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	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
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University of California, Irvine
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
PRS Account	University of California, Irvine
Verification Date	February 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP