ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
NCT ID: NCT00385021
Last Updated: 2007-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2006-10-31
2007-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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5-Fluorouracil, leucovorin, oxaliplatin, avastin
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
86 Years
ALL
No
Sponsors
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Southwestern Regional Medical Center
OTHER
Principal Investigators
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Petra Ketterl, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Locations
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Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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CTCT 06-06
Identifier Type: -
Identifier Source: org_study_id