Can a Triple-Drug cocktail slow advanced stomach cancer?
NCT ID NCT00183898
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of three FDA-approved drugs—oxaliplatin, capecitabine (Xeloda), and cetuximab—can slow tumor growth in people with advanced or metastatic gastric or gastroesophageal cancer that has not been treated with chemotherapy before. The study measures how long it takes for the cancer to progress, how many tumors shrink, and how long patients live. Researchers are also looking at genetic markers in tumors and blood to see if they can predict who will benefit from the treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of three drugs: oxaliplatin, capecitabine (Xeloda), and cetuximab
- What this could lead to
- If successful, this drug combination could offer a new first-line treatment option for people with advanced gastric or gastroesophageal cancer, potentially slowing tumor growth and extending survival.
- What could go wrong
- This is an early-phase (phase 2) trial with a small number of participants, so results may not apply to all patients. The drugs are not yet approved for this cancer type and may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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75 people
The number who actually took part.
- Started
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Dec 2004
- Finished
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Jun 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with histologically or cytologically confirmed advanced or metastatic gastric or gastroesophageal cancer. Histology must be consistent with adenocarcinoma. * No previous chemotherapy for metastatic or unresectable disease. Prior adjuvant therapy is allowed, as long as it was completed within six months of study initiation. * Ability to understand and willingness to sign a written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * SWOG performance status of less than or equal to 2. * At least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: \> 10 mm measured by spiral computed tomography (CT) or \> 20 mm measured by conventional techniques. * Have a negative serum or urine pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential). * Availability of tumor biopsy (paraffin embedded or fresh frozen) at the time of diagnosis and/or prior to study entry is required. * Patients must agree to use an effective form of birth control while on study and to continue this contraceptive method for 30 days from the date of the last study drug administration. 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: * Abnormal hematologic values (neutrophils \< 1.5 x 10\^9/L, platelet count \< 100 x 109/L) * Impaired renal function (estimated creatinine clearance \< 30 ml/min as calculated with Cockroft-Gault equation and serum creatinine \> 1.5 x upper normal limit). * Serum bilirubin \> 1.5 x upper normal limit. * ALT, AST \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases). * Alkaline phosphatase \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases or \> 10 x upper normal limit in the case of bone disease). * 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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