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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Roche Global Development | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after patients take the drugs capecitabine, oxaliplatin and cetuximab. Capecitabine (also called Xeloda) is a drug that has been approved by the Food and Drug Administration (FDA). Capecitabine has been approved for treatment of cancer of the colon and rectum. Oxaliplatin is another drug approved by the FDA. Oxaliplatin is also approved for treatment of cancer of the colon and rectum. Cetuximab is also a drug approved by the FDA for the treatment of cancer of the colon and rectum, as well as cancer of the head and neck. Capecitabine, oxaliplatin and cetuximab are not approved for gastric or gastroesophageal cancer. They are considered experimental drugs for this study. The purpose of this study is to see how long it takes patients' tumors to progress when they are taking oxaliplatin and capecitabine. Another purpose is to see how many tumors respond to this drug combination. The investigators also want to see how long people live when taking these drugs. The side effects of this drug combination will also be evaluated. This study will also measure the levels of certain genes (the cell's blueprint) in tumors. These genes affect how peoples' bodies react to the cancer drugs. Genes will also be measured in the blood. The investigators want to see how these genes can predict response to these study drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin and Capecitabine | Experimental | Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin, capecitabine | Drug | cetuximab 400 mg/m2, followed by weekly cetuximab 250 mg/m2 with oxaliplatin 130 mg/m2 on day 1 (every 3 weeks) with capecitabine 850 mg/m2 bid, daily on days 1-14, every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of patients, with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin, that have progressive disease within four months of the start of treatment | every 2 cyclec |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the time to progression, overall response rate and overall survival in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin | every 2 cycles | |
| To assess the toxicity of this regimen |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women.
Life expectancy of < 3 months.
Serious, uncontrolled, concurrent infection(s) or illness(es).
Any prior oxaliplatin treatment.
Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil or known DPD deficiency.
Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
Completion of previous chemotherapy regimen < four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitroureas), or with related toxicities unresolved prior to the start of study treatment.
Treatment for other carcinomas within the last five years, except for cured non-melanoma skin cancer and treated in-situ cervical cancer.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
History of persistent neurosensory disorder including but not limited to peripheral neuropathy
Evidence of central nervous system (CNS) metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Major surgery within 4 weeks of the start of study treatment, without complete recovery.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Any of the following laboratory values:
Unwillingness to participate or inability to comply with the protocol for the duration of the study.
Known, existing uncontrolled coagulopathy
Prior therapy which specifically and directly targets the EGFR pathway.
Prior severe infusion reaction to a monoclonal antibody
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| Name | Affiliation | Role |
|---|---|---|
| Syma Iqbal, M.D. | U.S.C./Norris Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S.C./Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 13, 2025 | |
| Reset | Oct 24, 2025 | |
| Release | Oct 27, 2025 |
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| every cycle |
| Reset | Nov 6, 2025 |
| Release | Jun 5, 2026 |
| Reset | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 13, 2025 | Oct 24, 2025 | |||
| Oct 27, 2025 | Nov 6, 2025 | |||
| Jun 5, 2026 | Jul 1, 2026 | |||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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