Colorectal CancerPhase 2NCT00044343
GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin
A Phase 2 study testing lapatinib in people with Colorectal Cancer, run by GlaxoSmithKline at 57 sites in 2 countries.
Trial summary
The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin. 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?
- lapatinib
- How many people
- 80 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Sep 2002to Oct 2003
- 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
- Provide signed informed consent.
- Refractory Stage IV metastatic colorectal cancer.
- Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
- No more than one prior therapy.
- Tumor tissue available for testing.
- 4 weeks since first-line cancer regimen.
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- Able to swallow and retain oral medication.
- Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
- Adequate kidney and liver function.
- Adequate bone marrow function.
Who cannot join
- Pregnant or lactating female.
- Conditions that would affect absorption of an oral drug
- First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- Severe cardiovascular disease or cardiac (heart) disease requiring a device.
- Active infection.
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- Brain metastases.
- Concurrent cancer therapy or investigational therapy.
- Use of oral or intravenous steroids.
- Unresolved or unstable, serious toxicity from prior therapy.
- Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States50 sites
GSK Clinical Trials Call Center
Altoona, Pennsylvania, 16601
GSK Clinical Trials Call Center
Armonk, New York, 10504
GSK Clinical Trials Call Center
Atlanta, Georgia, 30309
GSK Clinical Trials Call Center
Bethlehem, Pennsylvania, 18015
GSK Clinical Trials Call Center
Billings, Montana, 59101
GSK Clinical Trials Call Center
Boca Raton, Florida, 33428
GSK Clinical Trials Call Center
Brooklyn, New York, 11235
GSK Clinical Trials Call Center
Burien, Washington, 98166
GSK Clinical Trials Call Center
Charlotte, North Carolina, 28203
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45219
GSK Clinical Trials Call Center
Des Moines, Iowa, 50314
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33308
GSK Clinical Trials Call Center
Fort Myers, Florida, 33901
GSK Clinical Trials Call Center
Germantown, Tennessee, 38138
GSK Clinical Trials Call Center
Goldsboro, North Carolina, 27534
GSK Clinical Trials Call Center
Great Falls, Montana, 59405
GSK Clinical Trials Call Center
Greensboro, North Carolina, 27403
GSK Clinical Trials Call Center
Greenville, North Carolina, 27834
GSK Clinical Trials Call Center
Hershey, Pennsylvania, 17033
GSK Clinical Trials Call Center
Hickory, North Carolina, 28602
GSK Clinical Trials Call Center
Hooksett, New Hampshire, 03106-2505
GSK Clinical Trials Call Center
Kingston, Pennsylvania, 18704
GSK Clinical Trials Call Center
Lafayette, Louisiana, 70506
GSK Clinical Trials Call Center
Lancaster, Pennsylvania, 17605
GSK Clinical Trials Call Center
Los Angeles, California, 90095
GSK Clinical Trials Call Center
Marietta, Georgia, 30060
GSK Clinical Trials Call Center
Miami, Florida, 33138
GSK Clinical Trials Call Center
Morristown, New Jersey, 07960
GSK Clinical Trials Call Center
Nashville, Tennessee, 37203
GSK Clinical Trials Call Center
Nashville, Tennessee, 37205
GSK Clinical Trials Call Center
New Orleans, Louisiana, 70121
GSK Clinical Trials Call Center
New York, New York, 10032
GSK Clinical Trials Call Center
Olympia, Washington, 98502
GSK Clinical Trials Call Center
Omaha, Nebraska, 68198-7680
GSK Clinical Trials Call Center
Poway, California, 92064
GSK Clinical Trials Call Center
Puyallup, Washington, 98372
GSK Clinical Trials Call Center
Rockville, Maryland, 20850
GSK Clinical Trials Call Center
Rockville Centre, New York, 11570
GSK Clinical Trials Call Center
Saint Charles, Missouri, 63301
GSK Clinical Trials Call Center
Saint Joseph, Missouri, 64507
GSK Clinical Trials Call Center
Sarasota, Florida, 34239
GSK Clinical Trials Call Center
Spartanburg, South Carolina, 29303
GSK Clinical Trials Call Center
St Louis, Missouri, 63136
GSK Clinical Trials Call Center
Summit, New Jersey, 07091
GSK Clinical Trials Call Center
Terre Haute, Indiana, 47802
GSK Clinical Trials Call Center
Torrington, Connecticut, 06790
GSK Clinical Trials Call Center
Wellesley, Massachusetts, 02481
GSK Clinical Trials Call Center
West Columbia, South Carolina, 29169
GSK Clinical Trials Call Center
White Plains, New York, 10601
GSK Clinical Trials Call Center
Yakima, Washington, 98902
Canada7 sites
GSK Clinical Trials Call Center
Edmonton, Alberta, T6G 1Z2
GSK Clinical Trials Call Center
Greater Sudbury, Ontario, P3E 5J1
GSK Clinical Trials Call Center
Lévis, Quebec, G6V 3Z1
GSK Clinical Trials Call Center
Montreal, Quebec, H4J1C5
GSK Clinical Trials Call Center
Sainte-Foy, Quebec, G1V 4G5
GSK Clinical Trials Call Center
Thunder Bay, Ontario, P7A 7T1
GSK Clinical Trials Call Center
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin
The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
- Conditions
- Colorectal Cancer
- Being tested
- lapatinib
- Keywords
- colorectal cancer, EGFR inhibitor, lapatinib, metastatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (complete or partial).
Measured: 6 Months
Secondary outcomes (1)
Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2002 (estimated)
- Study startSep 2002
- Primary completionOct 2003
- Study completionOct 2003
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.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trial, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044343
- Sponsor's protocol ID
- EGF20004
- Status last verified
- Jul 2014
- First submitted
- 26 Aug 2002
- Last updated
- 10 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin
- ClinicalTrials.gov ID
- NCT00044343
- Acronym / sponsor ID
- EGF20004
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, EGFR inhibitor, lapatinib, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 28 Aug 2002 (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 purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
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)
- Provide signed informed consent.
- Refractory Stage IV metastatic colorectal cancer.
- Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
- No more than one prior therapy.
- Tumor tissue available for testing.
Key exclusion criteria (11 listed)
- Pregnant or lactating female.
- Conditions that would affect absorption of an oral drug
- First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- Severe cardiovascular disease or cardiac (heart) disease requiring a device.
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 |
|---|---|---|
| lapatinib | Drug | – |
Primary outcome
Tumor response rate (complete or partial).
Time frame: 6 Months
1 secondary outcome
Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
Time frame: 6 Month
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 10 Jul 2014.
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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.
GSK Clinical Trial, MD study director
GlaxoSmithKline
57 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 lapatinib in people with Colorectal Cancer, run by GlaxoSmithKline at 57 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 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, 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?
Tumor response rate (complete or partial). (time frame: 6 Months). 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 10 Jul 2014.