Gastrointestinal NeoplasmPhase 2IXOGoo1NCT01129310
First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.
A Phase 2 study testing Irinotecan-Capecitabine-Oxaliplatin in people with Gastrointestinal Neoplasm and Gastric Adenocarcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm, Gastric Adenocarcinoma
- What is being tested?
- Irinotecan-Capecitabine-Oxaliplatin
- Type of treatment
- Injection or infusion
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to 18 May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- histologically documented gastric GEJ adenocarcinoma not previously treated with palliative systemic therapy.
- Metastatic disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST.
- ECOG performance status of 0,1 or 2.
- Age ≥ 18 years
- Life expectancy of least 3 months based on discretion of treating oncologist.
- Adequate hematologic, hepatic, and renal function.
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- Patients who have received prior chemotherapy or radiation delivered as part of initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are permitted as long as that treatment was completed at least 6 months prior to study start date.
- Patients may have received prior palliative radiotherapy (unless radiation was curative therapy to pelvis or to ≥25% of bone marrow stores) if this radiation was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
- Patients may have received prior surgery if this surgery was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
- Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
Who cannot join
- Patients who have received palliative chemotherapy for their metastatic gastric or GEJ tumor.
- Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.
- Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.
- Previous of concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.
- Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure,unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that .....
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- Gilbert's disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pre-existing neuropathy ≥ grade 2 from any cause.
- Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement.
- Pregnant of lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma.
The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.
Read the detailed description
This is a single arm, open-label, multicentre, phase II trial in which patients with metastatic gastric or GEJ adenocarcinoma will be treated with the combination of irinotecan, capecitabine, and oxaliplatin (IXO).Patients will receive the combination of irinotecan, capecitabine, and oxaliplatin at the recommended phase II dose and sequence determined by the completed phase I trial. Patients will be treated on study until disease progression, overwhelming toxicity, or consent withdrawal.
- Conditions
- Gastrointestinal Neoplasm, Gastric Adenocarcinoma
- Being tested
- Irinotecan-Capecitabine-Oxaliplatin
- Keywords
- irinotecan, capecitabine, oxaliplatin, health-related quality of life, gastroesophageal(GE) junction adenocarcinoma
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan-Capecitabine-OxaliplatinDrug
Also called Camptosar; Xeloda; Eloxatin
Irinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate and dose limiting toxicity
Measured: 2 years
Secondary outcomes (1)
Progression Free Survival, overall survival, death, alterations in quality of life outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJul 2010
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Jennifer Spratlin, MD, Study chair, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129310
- Sponsor's protocol ID
- IXOGoo1 25412
- Acronym
- IXOGoo1
- Status last verified
- Jan 2016
- First submitted
- 21 May 2010
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT01129310
- Acronym / sponsor ID
- IXOGoo1 / IXOGoo1 25412
- Conditions
- Gastrointestinal Neoplasm, Gastric Adenocarcinoma
- Keywords
- irinotecan, capecitabine, oxaliplatin, health-related quality of life, gastroesophageal(GE) junction adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2010
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.
Detailed description
This is a single arm, open-label, multicentre, phase II trial in which patients with metastatic gastric or GEJ adenocarcinoma will be treated with the combination of irinotecan, capecitabine, and oxaliplatin (IXO).Patients will receive the combination of irinotecan, capecitabine, and oxaliplatin at the recommended phase II dose and sequence determined by the completed phase I trial. Patients will be treated on study until disease progression, overwhelming toxicity, or consent withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically documented gastric GEJ adenocarcinoma not previously treated with palliative systemic therapy.
- Metastatic disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST.
- ECOG performance status of 0,1 or 2.
- Age ≥ 18 years
- Life expectancy of least 3 months based on discretion of treating oncologist.
Key exclusion criteria (11 listed)
- Patients who have received palliative chemotherapy for their metastatic gastric or GEJ tumor.
- Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.
- Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.
- Previous of concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan-Capecitabine-OxaliplatinAlso: Camptosar; Xeloda; EloxatinIrinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1 | Drug | – |
Primary outcome
Overall Response Rate and dose limiting toxicity
Time frame: 2 years
1 secondary outcome
Progression Free Survival, overall survival, death, alterations in quality of life outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Spratlin, MD study chair
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan-Capecitabine-Oxaliplatin in people with Gastrointestinal Neoplasm and Gastric Adenocarcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 10 inclusion and 11 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 25 Feb 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Response Rate and dose limiting toxicity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.