Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma

NCT ID: NCT00256321

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-08-31

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.

Conditions

Gastric Carcinoma; Gastroesophageal Junction Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 70mg/m2 IV on Days 1 and 8

Capecitabine

Intervention Type: DRUG

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

Celecoxib

Intervention Type: DRUG

Celecoxib 400mg PO BID from Days 1 through 21.

Interventions

Oxaliplatin

Oxaliplatin 70mg/m2 IV on Days 1 and 8

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Celecoxib

Celecoxib 400mg PO BID from Days 1 through 21.

Intervention Type: DRUG

Other Intervention Names

Eloxatin; Xeloda; Celebrex

Eligibility 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 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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Chao Family Comprehensive Cancer Center

Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randall Holcombe, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center

Orange, California, United States

Countries

United States

Other Identifiers

2003-3414

Identifier Type: OTHER

Identifier Source: secondary_id

UCI 03-34

Identifier Type: -

Identifier Source: org_study_id