Gastric CancerPhase 2NCT00447967
Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients
A Phase 2 study testing Irinotecan, Oxaliplatin and Fluorouracil in people with Gastric Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
Trial summary
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Irinotecan, Oxaliplatin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesGreece
- Study dates
- Jul 2004to Sep 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced or metastatic gastric cancer.
- Measurable or evaluable disease.
- Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
- Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
- Karnofsky performance status > 70%.
- Age ≥18 years.
- Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.
- Patients must be able to understand the nature of this study and give written informed consent.
Who cannot join
- Active infection
- History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
- Patients with CNS metastases
- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
- Malnutrition or loss of > 10% of body weight during the last month.
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- Peripheral neuropathy ≥ grade 2
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- Psychiatric illness or social situation that would preclude study compliance.
- Pregnant or lactating women.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Crete
Heraklion, Crete, 71110
State General Hospital of Larissa
Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
About this study
Official title: A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer
Read the detailed description
There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.
Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials
- Conditions
- Gastric Cancer
- Being tested
- Irinotecan, Oxaliplatin, Fluorouracil, Leucovorin
- Keywords
- Metastatic Gastric Cancer, Oxaliplatin, Irinotecan
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT-11
Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
OxaliplatinDrug
Also called LoHP
Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
FluorouracilDrug
Also called 5-FU
Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
LeucovorinDrug
Also called LV
Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
OxaliplatinDrug
Also called LoHP
Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IOX Receives: Drug: Irinotecan; Drug: Oxaliplatin |
| 2 | Experimental | FLOX Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rates
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Secondary outcomes (5)
Time to progression
Measured: 1 year
Toxicity
Measured: Toxicity assessment on each chemotherapy cycle
Overall survival
Measured: 1 year
Quality of life
Measured: Assessment every two cycles
Symptoms improvement
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startJul 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Ioannis Boukovinas, MD, Principal investigator, "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447967
- Sponsor's protocol ID
- CT/04.18
- Status last verified
- Sep 2009
- First submitted
- 14 Mar 2007
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00447967
- Acronym / sponsor ID
- CT/04.18
- Conditions
- Gastric Cancer
- Keywords
- Metastatic Gastric Cancer, Oxaliplatin, Irinotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jul 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Mar 2007 (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.
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer
Detailed description
There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.
Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irinotecan, Drug: OxaliplatinIOX |
| 2 | Experimental | Drug: Fluorouracil, Drug: Leucovorin, Drug: OxaliplatinFLOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed locally advanced or metastatic gastric cancer.
- Measurable or evaluable disease.
- Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
- Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
- Karnofsky performance status > 70%.
Key exclusion criteria (10 listed)
- Active infection
- History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
- Patients with CNS metastases
- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
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 |
|---|---|---|
| IrinotecanAlso: CPT-11Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles | Drug | 1 |
| OxaliplatinAlso: LoHPOxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles | Drug | 1 |
| FluorouracilAlso: 5-FUFluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles | Drug | 2 |
| LeucovorinAlso: LVLeucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles | Drug | 2 |
| OxaliplatinAlso: LoHPOxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles | Drug | 2 |
Primary outcome
Objective Response Rates
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
5 secondary outcomes
Time to progression
Time frame: 1 year
Toxicity
Time frame: Toxicity assessment on each chemotherapy cycle
Overall survival
Time frame: 1 year
Quality of life
Time frame: Assessment every two cycles
Symptoms improvement
Time frame: Assessment every two cycles
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 28 Sep 2009.
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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.
Ioannis Boukovinas, MD principal investigator
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
8 sites 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, Oxaliplatin and Fluorouracil in people with Gastric Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
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 8 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 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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?
Objective Response Rates (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)). 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 28 Sep 2009.