Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-11-30

Brief Summary

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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 how well giving irinotecan together with cediranib works in treating patients with metastatic colorectal cancer that did not respond to previous oxaliplatin, fluoropyrimidine, and bevacizumab.

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Detailed Description

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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.

Secondary

* To determine objective response rate.
* To determine overall survival.
* To further define the dosing and safety profile of irinotecan hydrochloride and cediranib.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral cediranib once daily 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 up every 3 months for up to 2 years from study entry.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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irinotecan + cediranib

Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral cediranib once daily 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 up every 3 months for up to 2 years from study entry.

Group Type EXPERIMENTAL

cediranib maleate

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

Interventions

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cediranib maleate

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bert H. O'Neil, MD

Role: STUDY_CHAIR

UNC Lineberger Comprehensive Cancer Center

Locations

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Evanston Hospital

Evanston, Illinois, United States

Site Status

Elkhart Clinic, LLC

Elkhart, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status