Phase 2
N=136
Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01079780 ↗Enrolled (actual)
136
Serious AEs
55.3%
Results posted
Jun 2022
Primary outcome: Primary: Progression-free Survival — 5.98; 7.03; 9.20 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Biological); ramucirumab (Biological); irinotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
5.98; 7.03; 9.20 | — |
| SECONDARY Proportion of Participants With an Objective Response Rate (CR or PR) |
0.23; 0.44; 0.36 | 0.27 |
| SECONDARY Proportion of Patients With Grade 3 or Higher Treatment-related Adverse Events |
0.49; 0.81; 0.56 | — |
| SECONDARY Overall Survival |
19.3; 15.0; 19.2 | 0.55 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT01079780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.