Colorectal CancerPhase 2NCT00449163
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
A Phase 2 study testing Bevacizumab, Floxuridine and Irinotecan in people with Colorectal Cancer, run by University of Miami at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Bevacizumab, Floxuridine and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2006to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have stage IV, histologically confirmed diagnosis of Adenocarcinoma of the colon.
- Patients must have bi-dimensionally measurable disease since the purpose of this study is to determine efficacy of treatment.
- Patients must be previously untreated.
- Patients must be over the age of 18 years.
- Patients may not be pregnant. Patients of childbearing years must be using contraception.
- Patients must have ECOG performance status of 0-1 or KPS of at least 70.
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- Patients must have life expectancy of ≥ two months.
- Patients must have a white blood cell count of ≥1000/mm³ ANC > 1.0, platelets > 100,000/mm³.
- Patients must have adequate renal function as documented by a serum creatinine of ≤ 1.5 mg/dl.
- Patients must have a bilirubin of ≤ 1.5 mg/dl and an SGOT of ≤ three times normal for patients with no liver disease, and ≤ five times normal for those with liver metastases.
- Patients must be informed of the investigational nature of the study and give written informed consent.
- Patients must have indwelling central venous catheter or good peripheral intravenous catheter, preferably a port-a-cath.
- Patients may have had prior surgery for their colorectal cancer. Patients must be at least 8 weeks beyond surgery and recovered from all effects of surgery.
- Patients enrolled in this study may have a history of prior malignancy (5 years ago) provided that the patient is currently disease-free.
Who cannot join
- Patients who have had prior chemotherapy or radiation therapy for their colorectal cancer, with exception of adjuvant chemo/radiation therapy.
- Patients receiving concomitant radiation, hormonal therapy, chemotherapy, or immunotherapy.
- Patients receiving any investigational drug within 30 days prior to start of this study.
- Patients with serious underlying medical illnesses (including Congestive Heart Failure New York Heart Association Functional Classification 2-4) or active infection.
- Patients with central nervous system metastasis must have completed radiation prior to entry into this protocol.
- Patients with psychiatric conditions or associated conditions which would make participating in this study dangerous to their health.
- Patients with uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.
Read the detailed description
For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment delivered on weeks 3 \& 6 (Days 15 and 36).
Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab, Floxuridine, Irinotecan, Leucovorin
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
Also called Avastin
FloxuridineDrug
Also called 5-fluorodeoxyuridine
IrinotecanDrug
Also called Irinotecan Hydrochloride, Camptosar
LeucovorinDrug
Also called Leucovorin calcium
| Study group | Role | What they receive |
|---|---|---|
| Combination Chemotherapy and Bevacizumab | Experimental | Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29. Receives: Biological: Bevacizumab; Drug: Floxuridine; Drug: Irinotecan; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival up to 2 Years
Percentage of patients with overall survival times of up to 2 years
Measured: 2 years
Secondary outcomes (3)
Response Rate (Complete Response and Partial Response)
Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0
Measured: 2 years
Median Progression-free Survival in Months
Median number of months subjects achieved progression-free survival
Measured: 2 years
Rate of Toxicity in Study Participants
Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study start1 Mar 2006
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Study terminated by University of Miami Institutional Review Board
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bach Ardalan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449163
- Sponsor's protocol ID
- 20060042
- Other IDs
- SCCC-2005145, WIRB-20060252
- Status last verified
- Apr 2017
- First submitted
- 15 Mar 2007
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL) B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi, and A. Livingstone Journal of Clinical Oncology 2009 27:15S, e15114-e15114
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00449163
- Acronym / sponsor ID
- 20060042
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by University of Miami Institutional Review Board
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Mar 2006 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 28 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.
Detailed description
For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment delivered on weeks 3 \& 6 (Days 15 and 36).
Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Chemotherapy and Bevacizumab | Experimental | Biological: Bevacizumab, Drug: Floxuridine, Drug: Irinotecan, Drug: LeucovorinTreatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29: * Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22; * Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29; * Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29; * Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have stage IV, histologically confirmed diagnosis of Adenocarcinoma of the colon.
- Patients must have bi-dimensionally measurable disease since the purpose of this study is to determine efficacy of treatment.
- Patients must be previously untreated.
- Patients must be over the age of 18 years.
- Patients may not be pregnant. Patients of childbearing years must be using contraception.
Key exclusion criteria (7 listed)
- Patients who have had prior chemotherapy or radiation therapy for their colorectal cancer, with exception of adjuvant chemo/radiation therapy.
- Patients receiving concomitant radiation, hormonal therapy, chemotherapy, or immunotherapy.
- Patients receiving any investigational drug within 30 days prior to start of this study.
- Patients with serious underlying medical illnesses (including Congestive Heart Failure New York Heart Association Functional Classification 2-4) or active infection.
- Patients with central nervous system metastasis must have completed radiation prior to entry into this protocol.
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 |
|---|---|---|
| BevacizumabAlso: Avastin | Biological | Combination Chemotherapy and Bevacizumab |
| FloxuridineAlso: 5-fluorodeoxyuridine | Drug | Combination Chemotherapy and Bevacizumab |
| IrinotecanAlso: Irinotecan Hydrochloride, Camptosar | Drug | Combination Chemotherapy and Bevacizumab |
| LeucovorinAlso: Leucovorin calcium | Drug | Combination Chemotherapy and Bevacizumab |
Primary outcome
Overall Survival up to 2 Years
Time frame: 2 years
Percentage of patients with overall survival times of up to 2 years
3 secondary outcomes
Response Rate (Complete Response and Partial Response)
Time frame: 2 years
Median Progression-free Survival in Months
Time frame: 2 years
Rate of Toxicity in Study Participants
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationPhase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL) B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi, and A. Livingstone Journal of Clinical Oncology 2009 27:15S, e15114-e15114
- DOI: 10.1200/jco.2009.27.15s.e15114 Journal of Clinical Oncology 27, no. 15S - published online before print.Link 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.
Bach Ardalan, MD principal investigator
University of Miami
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 Bevacizumab, Floxuridine and Irinotecan in people with Colorectal Cancer, run by University of Miami 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 14 inclusion and 7 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 11 May 2017. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival up to 2 Years (time frame: 2 years). 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 NCT00449163, 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 11 May 2017.