Colorectal NeoplasmsPhase 2NCT00385021
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
A Phase 2 study testing 5-Fluorouracil, leucovorin, oxaliplatin, avastin in people with Colorectal Neoplasms, run by Southwestern Regional Medical Center at 1 site in United States.
Trial summary
To determine efficacy in the delivery of chronomodulated chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- 5-Fluorouracil, leucovorin, oxaliplatin, avastin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2007
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proof of adenocarcinoma in primary colon or rectum tumor.
- Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
- Ages 18 to 86 years.
- Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
- WHO/ECOG performance status < 3 (0, 1, or 2)
- Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
- Signed informed consent
Who cannot join
- Peripheral sensory neuropathy > or = grade 3.
- Serum bilirubin (total) > 3 X ULN.
- Symptomatic or uncontrolled brain metastasis.
- Metastases limited to bone, pleural effusion, or ascites.
- Uncontrolled overt cardiac disease.
- Uncontrolled hypercalcemia.
Show all 13Show fewer
- Uncontrolled infections.
- Uncontrolled hypertension (>180/110)
- History of GI perforation.
- History of arterial thromboembolic events.
- History of congestive heart failure.
- Patients taking warfarin (Coumadin).
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, 74133
About this study
To determine efficacy in the delivery of chronomodulated chemotherapy.
Read the detailed description
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.
It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.
- Conditions
- Colorectal Neoplasms
- Being tested
- 5-Fluorouracil, leucovorin, oxaliplatin, avastin
- Keywords
- Advanced, metastatic, colorectal, cancer, Avastin
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Fluorouracil, leucovorin, oxaliplatin, avastinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
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 posted6 Oct 2006 (estimated)
- Study startOct 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Petra Ketterl, MD, Principal investigator, Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385021
- Sponsor's protocol ID
- CTCT 06-06
- Status last verified
- Oct 2007
- First submitted
- 4 Oct 2006
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00385021
- Acronym / sponsor ID
- CTCT 06-06
- Conditions
- Colorectal Neoplasms
- Keywords
- Advanced, metastatic, colorectal, cancer, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Southwestern Regional Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Oct 2006 (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 determine efficacy in the delivery of chronomodulated chemotherapy.
Detailed description
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.
It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological proof of adenocarcinoma in primary colon or rectum tumor.
- Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
- Ages 18 to 86 years.
- Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
- WHO/ECOG performance status < 3 (0, 1, or 2)
Key exclusion criteria (13 listed)
- Peripheral sensory neuropathy > or = grade 3.
- Serum bilirubin (total) > 3 X ULN.
- Symptomatic or uncontrolled brain metastasis.
- Metastases limited to bone, pleural effusion, or ascites.
- Uncontrolled overt cardiac disease.
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 |
|---|---|---|
| 5-Fluorouracil, leucovorin, oxaliplatin, avastin | Drug | – |
Primary outcome
The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Petra Ketterl, MD principal investigator
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
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 5-Fluorouracil, leucovorin, oxaliplatin, avastin in people with Colorectal Neoplasms, run by Southwestern Regional Medical 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 7 inclusion and 13 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 2 Nov 2007. 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. 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?
The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen. (time frame: 2 years). 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 2 Nov 2007.