Upper Gastrointestinal TumoursPhase 2NCT00220064
A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours
A Phase 2 study testing Irinotecan, 5-Fluorouracil, Leucovorin in people with Upper Gastrointestinal Tumours, run by Royal Marsden NHS Foundation Trust.
Trial summary
The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Tumours
- What is being tested?
- Irinotecan, 5-Fluorouracil, Leucovorin
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Nov 2005
- 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 proven adenocarcinoma or squamous cell carcinoma of the Oesophagus, O-G junction, stomach and pancreas, not amenable to surgical resection.
- Bidimensionally measurable disease, or unidimensional measurable disease accessible by CT scanning, not within previously irradiated areas.
- Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment.
- At least one previous chemotherapy regimen, given at least 4 weeks prior to inclusion in this study.
- No previous exposure to irinotecan.
- Adequate bone marrow function with platelets >100 X 109/L; WBC > 3 X 109/L; Neutrophils > 1.5 X 109/L at the time of study entry.
Show all 16Show fewer
- Satisfactory renal function, serum creatinine 135 mol/litre
- Satisfactory liver function:
- In the absence of liver metastases:- Bilirubin < 1.25N (N=upper limit of normal range) Hepatic transaminases < 2.5N Prothrombin time < 1.5N
- In the presence of liver metastases:- Bilirubin < 1.5N Hepatic transaminases < 5N Prothrombin time < 1.5N
- No uncontrolled medical condition
- No previous malignant disease except for non-melanotic skin cancer or in-situ carcinoma of the uterine cervix.
- ECOG performance status of 0, 1 or 2.
- Predicted life expectancy of > 3 months.
- Adequate contraceptive precautions
- Informed written consent
Who cannot join
- Medical or psychiatric conditions resulting in inability of patient to give written consent.
- ECOG Performance status >2
- Intracerebral metastases or meningeal carcinomatosis
- Unresolved bowel obstruction
- Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4).
- Pregnancy/lactation
- Previous malignancy other than adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ.
About this study
Official title: A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.
The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.
- Conditions
- Upper Gastrointestinal Tumours
- Being tested
- Irinotecan, 5-Fluorouracil, Leucovorin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, 5-Fluorouracil, LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease stabilization rate or tumour marker response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2000
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal TumoursStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David Cunningham, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220064
- Sponsor's protocol ID
- 1810
- Status last verified
- May 2013
- First submitted
- 19 Sep 2005
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
- ClinicalTrials.gov ID
- NCT00220064
- Acronym / sponsor ID
- 1810
- Conditions
- Upper Gastrointestinal Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Jul 2000
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Sep 2005 (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 objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.
The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.
Study design
- Primary purpose
- Diagnosis
- 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 (16 listed)
- Histologically proven adenocarcinoma or squamous cell carcinoma of the Oesophagus, O-G junction, stomach and pancreas, not amenable to surgical resection.
- Bidimensionally measurable disease, or unidimensional measurable disease accessible by CT scanning, not within previously irradiated areas.
- Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment.
- At least one previous chemotherapy regimen, given at least 4 weeks prior to inclusion in this study.
- No previous exposure to irinotecan.
Key exclusion criteria (7 listed)
- Medical or psychiatric conditions resulting in inability of patient to give written consent.
- ECOG Performance status >2
- Intracerebral metastases or meningeal carcinomatosis
- Unresolved bowel obstruction
- Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4).
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, 5-Fluorouracil, Leucovorin | Drug | – |
Primary outcome
Disease stabilization rate or tumour marker response
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 31 May 2013.
Related trials for Upper Gastrointestinal Tumours
Enrolling by invitation
Immunonutrition for Surgical Prehabilitation of Patients With Upper GI Cancer
Upper GI Cancer
Active, not recruitingPhase 1/2
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
Advanced Solid Tumor Historically Known for High EphA2 Expression, Urothelial Cancer
Recruiting
Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer
Early-stage Upper Gastrointestinal Cancer, Stomach Cancer, Adenocarcinoma
Not yet recruiting
Prehabilitation for Upper Gastrointestinal Tract Cancer Surgery
Surgery of Upper Gastrointestinal Tract Cancer
Active, not recruitingPhase 2
A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
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.
David Cunningham principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, 5-Fluorouracil, Leucovorin in people with Upper Gastrointestinal Tumours, run by Royal Marsden NHS Foundation Trust.
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 16 inclusion and 7 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease stabilization rate or tumour marker response. 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 31 May 2013.