Colorectal CancerPhase 2NCT00165867
An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin
A Phase 2 study testing E7070 in people with Colorectal Cancer, run by Eisai Limited at 7 sites in 2 countries.
Trial summary
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- E7070
- How many people
- 40 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2005to not given
- 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
- Ambulant male or female patients with metastatic colorectal cancer who have been previously treated with 5-fluorouracil/leucovorin and oxaliplatin. Patients must fulfill the following criteria to be included in the study:
- At least 4 doses of previous treatment with oxaliplatin
- All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved
- At least one uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions)
- Aged greater than or equal to 18 years
- Histologically or cytologically confirmed colorectal cancer
- Karnofsky performance status greater than or equal to 70%
- Written informed consent to participate in the study
Who cannot join
- Patients with the following characteristics will not be included in the study:
- More than three previous lines of chemotherapy (including neo-adjuvant and adjuvant)
- Prior treatment with cytotoxics other than 5- fluorouracil/leucovorin (capecitabine and UFT are permitted) and oxaliplatin. Prior epidermal growth factor receptor targeted and anti-angiogenic therapy is permitted.
- Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases
- Any of the following laboratory parameters:
- hemoglobin <10 g/dl;
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- neutrophils <1.5 x 109/L;
- platelets <100 x 109/L;
- serum bilirubin >25 mmol/l (1.5 mg/dl);
- other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases);
- serum creatinine >1.5 x ULN;
- serum calcium (corrected for albumin) >=11.5 mg/dl. 5. History of Gilbert's Disease or conjugated hyperbilirubinemia 6. Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non- melanoma skin cancer or cervical intraepithelial neoplasia
- Uncontrolled infections
- Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
- Chronic inflammatory bowel disease and/or bowel obstruction
- History of hypersensitivity to sulfonamides
- History of severe hypersensitivity reactions to one of the excipients of irinotecan
- Treatment within two weeks before the start of the stud y with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine
- Any treatment with investigational drugs within 30 days before the start of the study
- Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
- Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
- History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
- Legal incapacity
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Beatson Oncology Centre
Glasgow, G11 6NT
Cookridge Hospital
Leeds, LS16 6QB
Leicester Royal Infirmary
Leicester, LE1 5WW
France3 sites
Hôpitaux Civils de Colmar
Colmar, F- 68024
CRLC Val d'Aurelle
Montpellier, F-34298
Centre Antoine Lacassagne
Nice, F-06189
About this study
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).
- Conditions
- Colorectal Cancer
- Being tested
- E7070
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7070Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate as defined by RECIST criteria.
Secondary outcomes (4)
Duration of response
time to progression
overall survival
safety and tolerability of the combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jantien Wanders, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165867
- Sponsor's protocol ID
- E7070-E044-214
- Status last verified
- Oct 2006
- First submitted
- 13 Sep 2005
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin
- ClinicalTrials.gov ID
- NCT00165867
- Acronym / sponsor ID
- E7070-E044-214
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- First posted
- 14 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 overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).
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 (8 listed)
- Ambulant male or female patients with metastatic colorectal cancer who have been previously treated with 5-fluorouracil/leucovorin and oxaliplatin. Patients must fulfill the following criteria to be included in the study:
- At least 4 doses of previous treatment with oxaliplatin
- All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved
- At least one uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions)
- Aged greater than or equal to 18 years
Key exclusion criteria (23 listed)
- More than three previous lines of chemotherapy (including neo-adjuvant and adjuvant)
- Prior treatment with cytotoxics other than 5- fluorouracil/leucovorin (capecitabine and UFT are permitted) and oxaliplatin. Prior epidermal growth factor receptor targeted and anti-angiogenic therapy is permitted.
- Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases
- Any of the following laboratory parameters:
- Uncontrolled infections
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 |
|---|---|---|
| E7070 | Drug | – |
Primary outcome
The objective response rate as defined by RECIST criteria.
4 secondary outcomes
Duration of response
time to progression
overall survival
safety and tolerability of the combination
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 9 Oct 2006.
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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.
Jantien Wanders study director
Eisai Limited
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E7070 in people with Colorectal Cancer, run by Eisai Limited at 7 sites in 2 countries.
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 23 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 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, France. 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?
The objective response rate as defined by RECIST criteria.. 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 9 Oct 2006.