|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00588900 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: cediranib maleate Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Irinotecan and AZD2171 in Patients With Metastatic Colorectal Cancer After Progression on FOLFOX Plus Cetuximab or FOLFOX Plus Bevacizumab and Cetuximab |
| Estimated Enrollment: | 88 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
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:
Must have received one and only one prior regimen for metastatic disease
PATIENT CHARACTERISTICS:
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
No significant history of bleeding events or gastrointestinal (GI) perforation
No arterial thrombotic events within 6 months before beginning treatment, including any of the following:
PRIOR CONCURRENT THERAPY:
Completed any major surgery ≥ 4 weeks from start of treatment and completed any minor surgery ≥ 1 week prior to start of treatment
Patients on full-dose anticoagulation (e.g., warfarin) are eligible provided that both of the following criteria are met:
Contacts and Locations| United States, Illinois | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | Recruiting |
| La Porte, Indiana, United States, 46350 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Memorial Hospital of South Bend | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370 | |
| Howard Community Hospital | Recruiting |
| Kokomo, Indiana, United States, 46904 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Elkhart General Hospital | Recruiting |
| Elkhart, Indiana, United States, 46515 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Saint Joseph Regional Medical Center | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| South Bend Clinic | Recruiting |
| South Bend, Indiana, United States, 46617 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| United States, Iowa | |
| Hematology Oncology Associates of the Quad Cities | Recruiting |
| Bettendorf, Iowa, United States, 52722 | |
| Contact: Shobha R. Chitneni, MD, MBBS 563-355-7733 | |
| United States, Michigan | |
| Lakeland Regional Cancer Care Center - St. Joseph | Recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| Contact: Rafat H. Ansari, MD, FACP 574-234-5123 | |
| Oncology Care Associates, PLLC | Recruiting |
| Saint Joseph, Michigan, United States, 49085 | |
| Contact: Eric P. Lester, MD 269-985-0029 | |
| United States, Missouri | |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Alan P. Lyss, MD 314-996-5514 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Missouri Baptist Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63131 | |
| Contact: Alan P. Lyss, MD 314-996-5514 | |
| United States, Nebraska | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68124 | |
| Contact: Clinical Trials Office - Alegant Health Cancer Center at Berge 402-398-6060 | |
| Cancer Resource Center - Lincoln | Recruiting |
| Lincoln, Nebraska, United States, 68510 | |
| Contact: Alan R. Berg, MD 402-420-7000 | |
| Immanuel Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68122 | |
| Contact: Gamini S. Soori, MD, FACP, FRCP, MBA 402-393-3110 | |
| Creighton University Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68131-2197 | |
| Contact: Clinical Trials Office - Creighton University Medical Center 402-280-4100 | |
| CCOP - Missouri Valley Cancer Consortium | Recruiting |
| Omaha, Nebraska, United States, 68106 | |
| Contact: Gamini S. Soori, MD, FACP, FRCP, MBA 402-393-3110 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Jeffrey J. Kirshner, MD 315-472-7504 | |
| United States, North Carolina | |
| Kinston Medical Specialists | Recruiting |
| Kinston, North Carolina, United States, 28501 | |
| Contact: Peter R. Watson, MD 252-559-2200ext.201 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Rex Cancer Center at Rex Hospital | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Contact: Clinical Trials Office - Rex Cancer Center 919-784-7209 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Wayne Memorial Hospital, Incorporated | Recruiting |
| Goldsboro, North Carolina, United States, 27534 | |
| Contact: James N. Atkins, MD 919-580-0000 | |
| Study Chair: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
| Study ID Numbers: | CDR0000580967, CALGB-80502 |
| Study First Received: | December 20, 2007 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00588900 History of Changes |
| Health Authority: | Unspecified |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Camptothecin Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |