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
  Purpose

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.


Condition Intervention Phase
Gastric Carcinoma
Gastroesophageal Junction Carcinoma
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Celecoxib/Oxaliplatin/Capecitabine Combination Chemotherapy for Unresectable,Recurrent, or Metastatic Gastric/Gastroesophageal Junction Carcinoma

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Define response rates and time to progression

Secondary Outcome Measures:
  • Study adverse effects/safety profile of combination chemotherapy

Estimated Enrollment: 20
Study Start Date: October 2004
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256321

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00256321     History of Changes
Other Study ID Numbers: UCI 03-34
Study First Received: November 18, 2005
Last Updated: February 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Gastric Carcinoma
Gastroesophageal junction Carcinoma

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Celecoxib
Capecitabine
Oxaliplatin
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on October 19, 2014