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

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Drug: cediranib maleate; Drug: irinotecan hydrochloride

• Registration Number: NCT00588900
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-09
• Study Start: 2008-03
• Primary Completion: 2010-05
• Study Completion: 2011-11
• Results First Submitted: 2017-01-11
• Results First Submitted QC: 2017-01-11
• Status Verified: 2017-03
• Results First Posted: 2017-03-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
irinotecan + cediranib	irinotecan hydrochloride	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.
irinotecan + cediranib	cediranib maleate	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy	at 12 weeks	The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.

Secondary Outcome Measures

Name	Time	Method
Radiographic Response Rate	Up to 2 years	The proportion of patients who respond (completely or partially) to each combination regimen will be estimated.; Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Overall Survival	Up to 2 years	Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Trial Locations

Locations (31)

Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Elkhart Clinic, LLC; 🇺🇸 Elkhart, Indiana, United States

Elkhart General Hospital; 🇺🇸 Elkhart, Indiana, United States

Fort Wayne Medical Oncology and Hematology; 🇺🇸 Fort Wayne, Indiana, United States

Howard Community Hospital; 🇺🇸 Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services; 🇺🇸 La Porte, Indiana, United States

CCOP - Northern Indiana CR Consortium; 🇺🇸 South Bend, Indiana, United States

Memorial Hospital of South Bend; 🇺🇸 South Bend, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend; 🇺🇸 South Bend, Indiana, United States

Saint Joseph Regional Medical Center; 🇺🇸 South Bend, Indiana, United States

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