Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.

Key facts

Study ID

NCT01079780

Run by

Eastern Cooperative Oncology Group

People needed

136

Starts

2011-01-18

Expected to finish

2021-08-17

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable disease
• Histologically confirmed adenocarcinoma of the colon or rectum
• K-ras wild type based on either primary or metastatic tumor
• Must have received prior first-line therapy comprising oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal cancer
• Registration within 42 days since confirmed disease progression
• Performance status 0-1
• ANC ≥ 1,500/μL
• Platelet count ≥ 75,000/μL
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min
• Urine protein ≤ 1+ on dipstick or routine urinalysis (if ≥ 2+, a 24-hour urine collection must demonstrate < 1,000 mg of protein)
• Total bilirubin ≤ 2.0 mg/dL
• AST and ALT ≤ 3.0 times ULN (5.0 times ULN for patients with liver metastases)
• INR ≤ 1.6 (≤ 3.0 for patients on warfarin and no active bleeding [i.e., no bleeding within the past 14 days])
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• At least 28 days and no more than 90 days since prior bevacizumab
• Concurrent stable dose of oral anticoagulant or low-molecular weight heparin allowed

You may not qualify if…

• Brain or CNS metastases
• Pregnant or nursing
• Prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus bevacizumab for colorectal cancer
• Clinically significant (equivalent to NCI CTCAE grade 3-4) bleeding episodes within the past 3 months
• Active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Symptomatic or poorly controlled cardiac arrhythmia
• Uncontrolled thrombotic or hemorrhagic disorder
• Uncontrolled or poorly controlled hypertension despite standard medical management (e.g., consistently systolic BP > 160 mm Hg and diastolic BP > 90 mm Hg)
• Acute arterial thrombotic events within the past 6 months, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina
• Other cancer requiring therapy within the past 3 years except in situ carcinoma or nonmelanoma skin cancer
• Acute or subacute intestinal obstruction
• History of inflammatory bowel disease requiring pharmacological and/or surgical intervention within the past 12 months
• Known allergy to any of the treatment components
• Major surgery within the past 28 days
• Subcutaneous venous access device placement within the past 7 days

Where it is running

• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Parker Adventist Hospital — Parker, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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