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View Clinical Trial (Medical Research Study)
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Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer - NCT00588900-60201 (Clinical Trial 197688)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy197688.aspx
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| City: |
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Evanston |
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State:
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IL |
| Zip Code: |
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60201 |
| Conditions: |
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Colorectal Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Giving irinotecan together with cediranib may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying giving irinotecan together with cediranib
to see how well it works in treating patients with metastatic colorectal cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- To determine the proportion of patients who are free from progression at 12 weeks from
the start of second-line therapy for each of the two cohorts.
Secondary
- To determine objective response rate for each treatment cohort.
- To determine overall survival for the patients treated in each cohort.
- To further define the dosing and safety profile of irinotecan hydrochloride and
cediranib.
OUTLINE: Patients are stratified according to prior therapy (oxaliplatin-based therapy with
cetuximab [cohort A] vs oxaliplatin-based therapy with cetuximab and bevacizumab [cohort
B]).
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral
cediranib on days 1-21.
Treatment repeats every 21 days for at least 2 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for up to 2 years
from study entry. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically or cytologically documented metastatic colorectal cancer
- Patients with a history of histologically proven colorectal cancer treated by
surgical resection and who develop radiological or clinical evidence of
metastatic cancer do not require additional histological or cytological
confirmation of metastatic disease unless either of the following:
- An interval of greater than five years has elapsed between the primary
surgery and the development of metastatic disease
- The primary cancer was stage I
- The site of the primary lesion must be or have been confirmed endoscopically,
surgically, or radiologically to have been in the colon or rectum
- Must have measurable disease, defined as in at least one dimension (longest dimension
to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- Lesions that are considered nonmeasurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Must have received one and only one prior regimen for metastatic disease
- For Cohort A, prior therapy should consist of oxaliplatin plus a fluoropyrimidine
and cetuximab without bevacizumab
- Cohort B will consist of patients previously treated with oxaliplatin, a
fluoropyrimidine, cetuximab and bevacizumab
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 8 g/dL
- Leukocytes ≥ 3,000/mm³
- Calculated creatinine clearance > 50 mL/min
- ALT/AST ≤ 2.5 times upper limit of normal (ULN)
- Urine protein < 1+ protein OR protein < 1g by 24-hour urine collection and urine
protein:creatinine ratio < 1.0
- Total bilirubin normal (unless increase is felt to be secondary to tumor burden)
- Not pregnant or nursing
- Negative pregnancy test
- No known end-stage liver disease or active hepatitis
- No colonic or small bowel disorders (e.g., inflammatory bowel disease, Crohn's
disease, ulcerative colitis) that predispose to diarrhea in which the symptoms are
uncontrolled as indicated by baseline pattern of > 3 watery or soft stools daily in
patients without a colostomy or ileostomy
- Patients with a colostomy or ileostomy may be entered at investigator discretion
- History of hypertension allowed provided it is well controlled (BP < 150/90 mm Hg) on
a regimen of antihypertensive therapy
- No concurrent congestive heart failure (New York Heart Association class III or IV)
- No significant history of bleeding events or gastrointestinal (GI) perforation
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper
or lower GI bleeding) within 3 months prior to beginning treatment are not
eligible unless the source of bleeding has been surgically resected
- Patients with a history of GI perforation within 12 months prior to beginning
treatment are not eligible
- No arterial thrombotic events within 6 months before beginning treatment, including
any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina or angina requiring surgical or medical intervention within the
past 6 months
- Myocardial infarction
- No serious or nonhealing wound, ulcer, or bone fracture
- Patients with clinically significant peripheral artery disease (i.e., claudication on
ambulating less than one block) or any other arterial thrombotic event within 6 months
are also ineligible
- QTc interval ≤ 470 msec
- No personal or family history of long QT syndrome.
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Must have recovered from all acute toxicities of prior therapy for metastatic disease
except peripheral neuropathy
- At least 6 weeks between the last dose of bevacizumab and the first dose of cediranib
- Prior pelvic irradiation is allowed (as long as the measurable lesion is outside the
radiotherapy field)
- Completed any major surgery ≥ 4 weeks from start of treatment and completed any minor
surgery ≥ 1 week prior to start of treatment
- Insertion of a vascular access device is not considered major or minor surgery
from the standpoint of protocol eligibility
- Patients must have fully recovered from the procedure and have a fully healed
incision
- Patients on full-dose anticoagulation (e.g., warfarin) are eligible provided that both
of the following criteria are met:
- The patient has an in-range INR (usually between 2 and 3) on a stable dose of
oral anticoagulant or is on a stable dose of low molecular weight heparin
- The patient has no active bleeding or pathological condition that carries a high
risk of bleeding (e.g., tumor involving major vessels or known varices)
- Patients receiving anti-platelet agents are eligible
- Patients who are on daily prophylactic aspirin or anticoagulation for atrial
fibrillation are eligible
- The use of agents with strong proarrhythmic potential is not permitted during the
study
- Patients who received treatment on CALGB-C80405 and whose treatment failed are
eligible for this study |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 12, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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