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Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT00084617

Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma

A Phase 2 study testing oxaliplatin, irinotecan hydrochloride and capecitabine in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
oxaliplatin, irinotecan hydrochloride and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Mar 2004to Dec 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. Patients must have metastatic or inoperable locally advanced disease; GE Junction tumor location should be documented in the patient's medical record chart using the Siewert classification below:
  • Type I: Adenocarcinoma of the distal esophagus which usually arises from an area with specialized intestinal metaplasia of the esophagus and which may infiltrate the GE junction from above Type II: True carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the GE junction Type III: Subcardial gastric carcinoma which infiltrates the GE junction and distal esophagus from below
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
  • No prior chemotherapy for metastatic or recurrent disease is allowed; one course of neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiation therapy as primary treatment is acceptable; at least 4 weeks must have elapsed since prior radiation therapy; patients must have been off previous anti-cancer therapy for at least 4 weeks
  • Life expectancy of >= 12 weeks
  • ECOG performance status 0-2
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  • Hemoglobin >= 9.5 g/dL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Total bilirubin =< 1.5 mg/dL
  • Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • The effects of oxaliplatin, irinotecan, and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because these drugs are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; patients should have no greater than grade 2 neuropathy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan and capecitabine
  • Patients with NYHA classification III or IV heart disease are ineligible
  • Patients must not have a known hypersensitivity to 5-fluorouracil
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because the study drugs have the potential to cause teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with oxaliplatin, irinotecan or capecitabine
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
  • Patients who are unable to take oral medications are not eligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.

II. To assess the duration of total responses of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.

Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00084617
Study groupRoleWhat they receive
Treatment (oxaliplatin, irinotecan, capecitabine)ExperimentalPatients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: oxaliplatin; Drug: irinotecan hydrochloride; Drug: capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rates (RR) in Metastatic Gastric/GE Junction Tumors

    Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.

    Measured: at 12 weeks (after 2 cycles of treatment)

Secondary outcomes (2)

  1. Complete Response (CR) and Partial Response (PR) Duration

    The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    Measured: at 40 months from study activation

  2. Overall Survival

    Length of time patients survived after treatment

    Measured: at 40 months from study activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionOct 2008
  4. Study completionDec 2008

Resources

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084617
Sponsor's protocol ID
NCI-2012-03010
Other IDs
CASE 1203, CDR0000365464, U01CA062502
Status last verified
Jul 2013
First submitted
10 Jun 2004
Last updated
1 May 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin, irinotecan hydrochloride and capecitabine in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rates (RR) in Metastatic Gastric/GE Junction Tumors (time frame: at 12 weeks (after 2 cycles of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00084617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.

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