Metastatic Colorectal CancerPhase 2NCT00459901
Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Erlotinib and capecitabine in people with Metastatic Colorectal Cancer, run by Peter Kozuch at 1 site in United States.
Trial summary
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Erlotinib and capecitabine
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 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
- Patients who have histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma.
- Patients must be > 18 years old.
- Patients must have a performance status of > 60 on the Karnofsky scale
- Patients must have an expected life expectancy of at least 12 weeks.
- Patients must give written informed consent as per institutional and federal regulatory requirements.
- Patients must have measurable or evaluable disease .
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- Patients must have an absolute neutrophil count of > 1,500/mm3 and a platelet count > 100,000/mm3.
- Patients must have adequate liver and renal function defined by a bilirubin of < 2.0 mg/dl and a creatinine of < 1.5 mg/dl, respectively.
- Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.
Who cannot join
- Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly targeted
- Pregnant or lactating women
- Clinical signs of brain involvement or leptomeningeal disease
- Serious illness or medical conditions
- Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias
- Active infections
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- UnstaOphthalmic disorders that might increase the risk for epithelium related complications (bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis e.g.)
- GI tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis) or post surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency orequires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met).
- Prior invasive malignancies for less 5 years
- Known to be HIV positive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
Official title: Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.
Read the detailed description
Approximately 150,000 people are diagnosed with colorectal cancer in the United States each year. Forty to fifty thousand people eventually will develop metastatic colorectal cancer and 40,000 people die annually because of advanced or metastatic colorectal cancer. Cancer patients prefer oral therapy over intravenous therapy as palliative treatment if efficacy regarding response rate and response duration is not compromised. Therefore, development of a completely oral combination therapy that approximates or improves upon the clinical outcomes attained by the reference triple drug therapies should be a research priority. Compared with intravenous 5-fluourouracil/leucovorin as first-line treatment for metastatic colorectal cancer, oral capecitabine has demonstrated similar survival outcomes (approximately 12-13 months), response rates (15-20%), and response durations (4-5 months) in two multi-institutional international randomized phase III trials. Erlotinib (OSI-774, Tarceva) is an orally available inhibitor of human EGFR tyrosine kinase. The epidermal growth factor receptor (EGFR) is overexpressed in a variety of human cancers including colorectal cancer. The principal goal of anticancer treatment with tyrosine kinase inhibitors such as erlotinib is to restore normal cellular growth by interrupting EGFR mediated cell proliferation and malignant The hypothesis of this phase II trial is that the unique mechanisms of action and non-overlapping toxicity profiles of capecitabine (Xeloda) and erlotinib will allow these drugs to be combined into a safe and tolerable regimen with better activity regarding response, response duration, and median survival than capecitabine alone in patients with previously untreated metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Erlotinib and capecitabine
- Keywords
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib and capecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer
Measured: Time to tumor progression, time to confirmed response rate, time to treatment failure, .
Secondary outcomes (1)
To determine the qualitative and quantitative toxicity of this combination and sequence of drug administration
Measured: Objective response rate, duration of confirmed response rate, CEA response will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionJun 2005
Why it stopped: Study halted by drug manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Kozuch
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Genentech, Inc.
- Responsible party
- Sponsor-investigator, Peter Kozuch, Beth Israel Medical Center
- Investigators
- Peter Kozuch, MD, Principal investigator, Continuum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459901
- Sponsor's protocol ID
- 022-03
- Other IDs
- XEL308
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2007
- Last updated
- 29 Apr 2015
- Results posted
- No
Publications
Van Halteren HK, Roumen RM, Coebergh JW, Croiset van Uchelen FA, Keuning JJ, Vreugdenhil G. The impact of 5-FU-based bolus chemotherapy on survival in patients with advanced colorectal cancer. Anticancer Res. 1999 Jul-Aug;19(4C):3447-9.
PubMed 10629633
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00459901
- Acronym / sponsor ID
- 022-03
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted by drug manufacturer
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Peter KozuchUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Genentech, Inc.
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Apr 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.
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.
Detailed description
Approximately 150,000 people are diagnosed with colorectal cancer in the United States each year. Forty to fifty thousand people eventually will develop metastatic colorectal cancer and 40,000 people die annually because of advanced or metastatic colorectal cancer. Cancer patients prefer oral therapy over intravenous therapy as palliative treatment if efficacy regarding response rate and response duration is not compromised. Therefore, development of a completely oral combination therapy that approximates or improves upon the clinical outcomes attained by the reference triple drug therapies should be a research priority. Compared with intravenous 5-fluourouracil/leucovorin as first-line treatment for metastatic colorectal cancer, oral capecitabine has demonstrated similar survival outcomes (approximately 12-13 months), response rates (15-20%), and response durations (4-5 months) in two multi-institutional international randomized phase III trials. Erlotinib (OSI-774, Tarceva) is an orally available inhibitor of human EGFR tyrosine kinase. The epidermal growth factor receptor (EGFR) is overexpressed in a variety of human cancers including colorectal cancer. The principal goal of anticancer treatment with tyrosine kinase inhibitors such as erlotinib is to restore normal cellular growth by interrupting EGFR mediated cell proliferation and malignant The hypothesis of this phase II trial is that the unique mechanisms of action and non-overlapping toxicity profiles of capecitabine (Xeloda) and erlotinib will allow these drugs to be combined into a safe and tolerable regimen with better activity regarding response, response duration, and median survival than capecitabine alone in patients with previously untreated metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (9 listed)
- Patients who have histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma.
- Patients must be > 18 years old.
- Patients must have a performance status of > 60 on the Karnofsky scale
- Patients must have an expected life expectancy of at least 12 weeks.
- Patients must give written informed consent as per institutional and federal regulatory requirements.
Key exclusion criteria (10 listed)
- Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly targeted
- Pregnant or lactating women
- Clinical signs of brain involvement or leptomeningeal disease
- Serious illness or medical conditions
- Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias
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 |
|---|---|---|
| Erlotinib and capecitabine | Drug | – |
Primary outcome
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer
Time frame: Time to tumor progression, time to confirmed response rate, time to treatment failure, .
1 secondary outcome
To determine the qualitative and quantitative toxicity of this combination and sequence of drug administration
Time frame: Objective response rate, duration of confirmed response rate, CEA response will be assessed.
Results and safety
The study was stopped early (reason given: Study halted by drug manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 10629633Van Halteren HK, Roumen RM, Coebergh JW, Croiset van Uchelen FA, Keuning JJ, Vreugdenhil G. The impact of 5-FU-based bolus chemotherapy on survival in patients with advanced colorectal cancer. Anticancer Res. 1999 Jul-Aug;19(4C):3447-9.
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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.
Peter Kozuch, MD principal investigator
Continuum Cancer Center
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 Erlotinib and capecitabine in people with Metastatic Colorectal Cancer, run by Peter Kozuch at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 29 Apr 2015. 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 United States. 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 was stopped early (reason given: Study halted by drug manufacturer). Results are not available in the source record.
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?
To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer (time frame: Time to tumor progression, time to confirmed response rate, time to treatment failure, .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459901, which also lists 1 linked publication.
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 29 Apr 2015.