Colorectal CarcinomaPhase 2NCT00725400
Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma
A Phase 2 study testing Cetuximab and Radiation Therapy and Surgery and Radiation Therapy in people with Colorectal Carcinoma, run by American Scitech International at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Cetuximab and Radiation Therapy and Surgery and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage II- IV Colorectal Cancer
- Patients must be 40 years and older
- Patients may be of any race and either gender
- Signed Informed Consent
- Patient characteristics:
- Age: 40 years and older
Show all 38Show fewer
- Sex: Both
- Performance status: Not specified
- Life expectancy: Not specified
- Hematopoietic:
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- No history of significant bleeding events within the past 6 months
- Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- Albumin ≥ 2.5 g/dL
- Renal:
- Creatinine ≤ 1.5 times upper limit of normal
- Protein < 1+ by urinalysis
- Protein < 1 g by 24-hour urine collection
- Cardiovascular:
- No conduction defect in heart
- No congestive heart failure
- No myocardial infarction within last 6 months
- No cerebrovascular accident
- No uncontrolled hypertension
- No clinically significant peripheral artery disease
- Pulmonary:
- No pulmonary embolism
- No interstitial pneumonia
- No extensive or symptomatic interstitial fibrosis of the lung
- Neurologic:
- No uncontrolled seizure disorder
- No active neurological disease
- Other:
- Not pregnant or nursing
- Negative pregnancy test
Who cannot join
- Age below 40 years
- Brain or nervous system metastases
- Any current mental illness
- Hemoglobin is less than 9.0 g/dl
- CBC results are below normal range
- Patients with Hepatitis B or C or who are HIV positive
- Pregnant or nursing patients are not eligible for entry into the study
- Hepatic abnormality AST/ALT > 4 folds
Trial locations and contacts
1 site in 1 country.
United States1 site
Practicing Physician in New Jersey
Englishtown, New Jersey, 07726
About this study
Official title: Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma
RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor cells and cause less damage to normal tissue . Giving the drug Cetuximab together with Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue and possibly nearby lymph nodes. Surgery is usually used in conjunction with other conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation Therapy after surgery may kill any tumor cells that remain after surgery.
Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation.
PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to IV
Read the detailed description
OBJECTIVES:
Primary:
- Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.
Secondary:
- To determine the progression-free survival and overall survival of patients treated with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned into two different Arms.
Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24 months.
- Conditions
- Colorectal Carcinoma
- Being tested
- Cetuximab and Radiation Therapy, Surgery and Radiation Therapy
- Keywords
- Colorectal Cancer, Erbitux, Cetuximab, Surgery, Radiation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab and Radiation TherapyOther
Also called Erbitux and Radiotherapy
Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Surgery and Radiation TherapyProcedure or surgery
Also called Surgery and Radiotherapy
Patients will undergo Surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will receive a Cetuximab and Radiation Therapy. Receives: Other: Cetuximab and Radiation Therapy |
| 2 | Active comparator | Patients will undergo Surgery before or after Radiation Therapy. Receives: Procedure: Surgery and Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate
Measured: 4 year
Secondary outcomes (4)
Tolerability
Measured: 4 years
Progression free survival
Measured: 4 years
Overall survival
Measured: 4 Years
Quality of life
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Scitech International
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Investigators
- Ratna Grewal, MD, Study chair, American Scitech International- eCROPrem A Nandiwada, MD, Principal investigator, Raritan Bay Medical CenterSarat Babu, MD, Study director, St. Peter's HospitalS N Agrawal, MD, Principal investigator, JLR Hospital in India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725400
- Sponsor's protocol ID
- ASI-CRO0000192008
- Other IDs
- JLRH-0000292008, IORG-0000392008, BMS-192008, IMCL-II-ASI-IORG-92008, ASI-CRCII0708
- Status last verified
- Jul 2011
- First submitted
- 28 Jul 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00725400
- Acronym / sponsor ID
- ASI-CRO0000192008
- Conditions
- Colorectal Carcinoma
- Keywords
- Colorectal Cancer, Erbitux, Cetuximab, Surgery, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- American Scitech InternationalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Bristol-Myers Squibb
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 30 Jul 2008 (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.
RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor cells and cause less damage to normal tissue . Giving the drug Cetuximab together with Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue and possibly nearby lymph nodes. Surgery is usually used in conjunction with other conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation Therapy after surgery may kill any tumor cells that remain after surgery.
Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation.
PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to IV
Detailed description
OBJECTIVES:
Primary:
- Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.
Secondary:
- To determine the progression-free survival and overall survival of patients treated with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned into two different Arms.
Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Cetuximab and Radiation TherapyPatients will receive a Cetuximab and Radiation Therapy. |
| 2 | Active comparator | Procedure: Surgery and Radiation TherapyPatients will undergo Surgery before or after Radiation Therapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Patients with stage II- IV Colorectal Cancer
- Patients must be 40 years and older
- Patients may be of any race and either gender
- Signed Informed Consent
- Age: 40 years and older
Key exclusion criteria (8 listed)
- Age below 40 years
- Brain or nervous system metastases
- Any current mental illness
- Hemoglobin is less than 9.0 g/dl
- CBC results are below normal range
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 |
|---|---|---|
| Cetuximab and Radiation TherapyAlso: Erbitux and RadiotherapyPatients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy. | Other | 1 |
| Surgery and Radiation TherapyAlso: Surgery and RadiotherapyPatients will undergo Surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy. | Procedure or surgery | 2 |
Primary outcome
Objective tumor response rate
Time frame: 4 year
4 secondary outcomes
Tolerability
Time frame: 4 years
Progression free survival
Time frame: 4 years
Overall survival
Time frame: 4 Years
Quality of life
Time frame: 4 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Ratna Grewal, MD study chair
American Scitech International- eCRO
Prem A Nandiwada, MD principal investigator
Raritan Bay Medical Center
Sarat Babu, MD study director
St. Peter's Hospital
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 Cetuximab and Radiation Therapy and Surgery and Radiation Therapy in people with Colorectal Carcinoma, run by American Scitech International 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 38 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Jul 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 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 withdrawn before enrolling participants, so there are no results.
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?
Objective tumor response rate (time frame: 4 year). 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 20 Jul 2011.