Gastric CancerPhase 2NCT00183898
Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer
A Phase 2 study testing oxaliplatin, capecitabine in people with Gastric Cancer and Esophageal Cancer, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer
- What is being tested?
- oxaliplatin, capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2004to 19 Jun 2020
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase II Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer
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.
- Conditions
- Gastric Cancer, Esophageal Cancer
- Being tested
- oxaliplatin, capecitabine
- Keywords
- Gastroesophageal Junction Cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin, capecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin and Capecitabine | Experimental | Oxaliplatin given every 21 days Capecitabine given daily x 14 days every 21 days Receives: Drug: oxaliplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Progression-Free Survival (PFS) at Month 4
Progression-free survival will be measured from the start of treatment until the time the patient is first recorded as having disease progression, or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last visit for tumor measurement.
Measured: every 2 cycles (6 weeks), up to 4 months.
Secondary outcomes (5)
Time to Progression
The overall time to progression in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin. This differs from 4 months PFS rate outcome data, which assesses the progression-free survival at 4 months.
Measured: every 2 cycles (6 weeks), through study completion up to 2 years, 7 months
Number of Participants Who Experienced Toxicities During the Study Drug Regimen
Measured: About 2 years, 7 months
Overall Response Rate
To determine overall response rate in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Measured: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
Overall Survival
To determine overall survival in patients with advanced gastric or gastroesophageal junction cancer treated with a combination of capecitabine and oxaliplatin
Measured: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
Progression-free Survival (PFS)
Progression-free survival (PFS), Median (95%CI), months
Measured: Every 2 cycles (6 weeks), through study completion, up to 2 years, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start28 Dec 2004
- Primary completion4 Feb 2013
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Roche Global Development, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, M.D., Principal investigator, U.S.C./Norris Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183898
- Sponsor's protocol ID
- 3G-03-4
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No