Colon CancerPhase 1NCT00494611
A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
A Phase 1 study testing Peri operative Cetuximab. in people with Colon Cancer, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000 Americans die from colon cancer annually. To date, surgical resection remains the mainstay of treatment for colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Peri operative Cetuximab.
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2010
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be between 18 and 85 years of age and have biopsy proven adenocarcinoma of the large bowel at least 2 cm in size.
- Patients receiving preoperative study drug will not have undergone operation with resection and pathologic staging and so will be Stage 1 or 2 or 3 patients. Patients in groups who only receive postoperative study drug will be Stage 3 patients only.
- Patients may be of any race and either gender.
- Patients without evidence of Stage 4 cancer on the basis of preoperative chest X-rays, abdominal and pelvic CT scans (preferably with IV and oral contrast), or other metastatic work up (USG, PET, MRI) will be eligible for entry.
- Only those patients with colon tumors located between the proximal rectum (defined as 15 cm from the anal verge) and the cecum who are to undergo elective resection will be eligible for this study.
- Those patients with a reasonable performance status (ECOG Performance Status Scale score of O or 1) will be eligible for entry into the study.
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- Those patients whose renal, hepatic, and hematologic blood test values meet the following criteria will be eligible (as per the Columbia Presbyterian clinical chemistry lab):
- Hemoglobin >8.0g/dL
- Neutrophils >1.5 x 10^9/L
- Lymphocytes >1.2 x 10^9/L
- Platelets >100 x 10^9/L
- Serum creatinine <1.8 mg/dL
- Serum bilirubin <2mg/dL
- SGOT <41mg/dL
- SGPT <41mg/dL
Who cannot join
- Patients with tumors less than 2 cm in size or those with polyp cancers that have been fully removed or those who have had partial removal endoscopically where the remnant is less than 2 cm in size are not eligible.
- Patients with a history of a second current malignancy or past malignancy (within the past 5 years), other than the colon neoplasm in question (excepting basal cell skin carcinomas) will not be eligible for entry into this study.
- Patients with rectal cancer (located between the anus and 15 cm proximal to the anal verge) or Stage 4 colon cancer are not eligible.
- Patients with a history of immunosuppression secondary to a disease process, current steroid usage, or the use of other immunosuppressive drugs, within three months of the planned surgery, will not be eligible for this study.
- Patients with Hepatitis B or C or who are HIV positive will be excluded.
- Patients who have received chemotherapy or radiotherapy within 3 months of the anticipated surgery will not be eligible.
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- Patients with bowel obstruction, or other emergency indications for surgery, will not be eligible.
- Pregnant or nursing patients are not eligible for entry into the study.
- All WOCBP must have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient will not receive cetuximab and will not be eligible for entry into the study.
- In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors associated with an unintentional pregnancy in this setting. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.)
- The Investigator will immediately notify both the IRB and Bristol Meyers Squibb in the event of a confirmed pregnancy in a patient participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's Roosevelt Medical Center
New York, New York, 10019
About this study
There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000 Americans die from colon cancer annually. To date, surgical resection remains the mainstay of treatment for colon cancer. However, between 35% and 45% of patients, despite colon surgery, retain unseen tumor cells in the bloodstream or in small clumps in the liver or other tissues. It is for this reason that postoperative chemotherapy (anti-tumor drugs) is recommended and given to some patients after surgery. Conventional chemotherapy is usually started no earlier than 4 to 6 weeks after the colon cancer has been resected.
Despite surgery and conventional chemotherapy, a significant number of patients develop cancer recurrences and many go on to die from the cancer. For this reason, investigators continue to look for new cancer treatments and approaches. The study under consideration proposes to give colon cancer patients an anti-cancer therapy for 3 weeks before and for 3 weeks after undergoing operation to remove the colon cancer. This time period is referred to as the "perioperative period." Presently, around the world, doctors do not administer any type of anti-cancer therapy during the perioperative period. It is the belief of the investigators carrying out this study that this period may be an ideal time to fight the tumor and that treatment given during this time may improve survival and reduce cancer recurrence rates. Patients who choose to receive this biologic anti-cancer treatment immediately before and after surgery can also receive conventional chemotherapy at the usual time (4-6 weeks after surgery). Thus, this perioperative anti-cancer treatment would not interfere with the standard chemotherapy regimens used today.
Read more
The drug that is to be given in this study is called Cetuximab (also known as "Erbitux"). This is an anti-cancer drug which has already been approved by the FDA for use in patients who have colon cancer. This drug, like all of the other anti-cancer drugs used for treating colon cancer, has been given either well after surgery or to patients with very advanced disease who have not undergo surgery. What is unique about the St. Luke's Roosevelt study is that the drug will be given during the 3 weeks before surgery and for the first 3 weeks after the colon resection surgery.
To summarize, Cetuximab is a humanized antibody to EGFR which has been shown to be effective in killing tumor cells in patients with colon cancer.
In this study the Cetuximab is to be given 1) after the surgery, 2) immediately before the operation, or 3) both before and after surgery. Entry into the study means that the operation may be delayed for at least 3 weeks in order for the drug to be given. Since many patients who do not participate in any research studies wait at least that long for surgery this does not constitute a delay. The drug has a safety profile and has been well tolerated, in general. However, since thus far it has not been given in the weeks immediately prior to or immediately after major surgery there is no safety profile for this drug during the perioperative period. The primary goals of this preliminary study are to establish the safety of Cetuximab in the perioperative period and to demonstrate that the preoperative doses have an actual impact on the tumor cells themselves.
Read the detailed description
Cetuximab's tumor growth inhibitory mechanism directly blocks EGFR. After binding to EGFR, the antibody blocks signal transduction through the receptor with a subsequent inhibition of tumor cell proliferation and MMP expression. We hypothesize that peri-operative weekly administration of Cetuximab, a humanized monoclonal antibody to EGF receptor (EGFR), for 3 weeks immediately prior to surgery and for 3 weeks immediately after colon cancer surgery is safe. This drug has been demonstrated to be effective in Stage 4 colon cancer patients and is approved for use in colorectal cancer patients. Cetuximab has never been administered in the month immediately before or after colon surgery. Establishing the safety of Cetuximab in the perioperative setting is the primary objective of this study.
- Conditions
- Colon Cancer
- Being tested
- Peri operative Cetuximab.
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri operative Cetuximab.Drug
Also called Cetuximab (IMC-C225-marketed under the name Erbitux)
Cetuximab will be given immediately preoperative and early post surgery period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of peri operative Cetuximab.
Measured: within 90 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Unable to recruit subjects in timely fashion for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Richard L Whelan, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494611
- Sponsor's protocol ID
- AAAC3683
- Status last verified
- Jun 2010
- First submitted
- 28 Jun 2007
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT00494611
- Acronym / sponsor ID
- AAAC3683
- Conditions
- Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects in timely fashion for the study
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Jul 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.
There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000 Americans die from colon cancer annually. To date, surgical resection remains the mainstay of treatment for colon cancer. However, between 35% and 45% of patients, despite colon surgery, retain unseen tumor cells in the bloodstream or in small clumps in the liver or other tissues. It is for this reason that postoperative chemotherapy (anti-tumor drugs) is recommended and given to some patients after surgery. Conventional chemotherapy is usually started no earlier than 4 to 6 weeks after the colon cancer has been resected.
Despite surgery and conventional chemotherapy, a significant number of patients develop cancer recurrences and many go on to die from the cancer. For this reason, investigators continue to look for new cancer treatments and approaches. The study under consideration proposes to give colon cancer patients an anti-cancer therapy for 3 weeks before and for 3 weeks after undergoing operation to remove the colon cancer. This time period is referred to as the "perioperative period." Presently, around the world, doctors do not administer any type of anti-cancer therapy during the perioperative period. It is the belief of the investigators carrying out this study that this period may be an ideal time to fight the tumor and that treatment given during this time may improve survival and reduce cancer recurrence rates. Patients who choose to receive this biologic anti-cancer treatment immediately before and after surgery can also receive conventional chemotherapy at the usual time (4-6 weeks after surgery). Thus, this perioperative anti-cancer treatment would not interfere with the standard chemotherapy regimens used today.
The drug that is to be given in this study is called Cetuximab (also known as "Erbitux"). This is an anti-cancer drug which has already been approved by the FDA for use in patients who have colon cancer. This drug, like all of the other anti-cancer drugs used for treating colon cancer, has been given either well after surgery or to patients with very advanced disease who have not undergo surgery. What is unique about the St. Luke's Roosevelt study is that the drug will be given during the 3 weeks before surgery and for the first 3 weeks after the colon resection surgery.
To summarize, Cetuximab is a humanized antibody to EGFR which has been shown to be effective in killing tumor cells in patients with colon cancer.
In this study the Cetuximab is to be given 1) after the surgery, 2) immediately before the operation, or 3) both before and after surgery. Entry into the study means that the operation may be delayed for at least 3 weeks in order for the drug to be given. Since many patients who do not participate in any research studies wait at least that long for surgery this does not constitute a delay. The drug has a safety profile and has been well tolerated, in general. However, since thus far it has not been given in the weeks immediately prior to or immediately after major surgery there is no safety profile for this drug during the perioperative period. The primary goals of this preliminary study are to establish the safety of Cetuximab in the perioperative period and to demonstrate that the preoperative doses have an actual impact on the tumor cells themselves.
Detailed description
Cetuximab's tumor growth inhibitory mechanism directly blocks EGFR. After binding to EGFR, the antibody blocks signal transduction through the receptor with a subsequent inhibition of tumor cell proliferation and MMP expression. We hypothesize that peri-operative weekly administration of Cetuximab, a humanized monoclonal antibody to EGF receptor (EGFR), for 3 weeks immediately prior to surgery and for 3 weeks immediately after colon cancer surgery is safe. This drug has been demonstrated to be effective in Stage 4 colon cancer patients and is approved for use in colorectal cancer patients. Cetuximab has never been administered in the month immediately before or after colon surgery. Establishing the safety of Cetuximab in the perioperative setting is the primary objective of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must be between 18 and 85 years of age and have biopsy proven adenocarcinoma of the large bowel at least 2 cm in size.
- Patients receiving preoperative study drug will not have undergone operation with resection and pathologic staging and so will be Stage 1 or 2 or 3 patients. Patients in groups who only receive postoperative study drug will be Stage 3 patients only.
- Patients may be of any race and either gender.
- Patients without evidence of Stage 4 cancer on the basis of preoperative chest X-rays, abdominal and pelvic CT scans (preferably with IV and oral contrast), or other metastatic work up (USG, PET, MRI) will be eligible for entry.
- Only those patients with colon tumors located between the proximal rectum (defined as 15 cm from the anal verge) and the cecum who are to undergo elective resection will be eligible for this study.
Key exclusion criteria (12 listed)
- Patients with tumors less than 2 cm in size or those with polyp cancers that have been fully removed or those who have had partial removal endoscopically where the remnant is less than 2 cm in size are not eligible.
- Patients with a history of a second current malignancy or past malignancy (within the past 5 years), other than the colon neoplasm in question (excepting basal cell skin carcinomas) will not be eligible for entry into this study.
- Patients with rectal cancer (located between the anus and 15 cm proximal to the anal verge) or Stage 4 colon cancer are not eligible.
- Patients with a history of immunosuppression secondary to a disease process, current steroid usage, or the use of other immunosuppressive drugs, within three months of the planned surgery, will not be eligible for this study.
- Patients with Hepatitis B or C or who are HIV positive will be excluded.
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 |
|---|---|---|
| Peri operative Cetuximab.Also: Cetuximab (IMC-C225-marketed under the name Erbitux)Cetuximab will be given immediately preoperative and early post surgery period. | Drug | – |
Primary outcome
Safety of peri operative Cetuximab.
Time frame: within 90 days of surgery
Results and safety
The study was stopped early (reason given: Unable to recruit subjects in timely fashion for the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
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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.
Richard L Whelan, MD study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peri operative Cetuximab. in people with Colon Cancer, run by St. Luke's-Roosevelt Hospital Center 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 15 inclusion and 12 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 19 May 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Unable to recruit subjects in timely fashion for the study). 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?
Safety of peri operative Cetuximab. (time frame: within 90 days of surgery). 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 19 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.