Actively Recruiting
Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer
Led by Dominik Paul Modest · Updated on 2024-02-15
153
Participants Needed
1
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
FIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine / tipiracil and panitumumab (Arm A) compared to trifluridine / tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer. The primary objectives of this study is to compare the effecacy of treatment with trifluridine / tipiracil plus panitumumab versus trifluridine / tipiracil plus bevacizumab.
CONDITIONS
Official Title
Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from the patient
- Patient is 18 years or older at the time of consent
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic colorectal cancer with at least one measurable lesion by CT or MRI within 5 weeks before randomization
- Metastases are primarily unresectable or patient cannot or will not undergo surgery
- RAS wild-type metastatic colorectal cancer confirmed by validated test
- Patient is not eligible for or unwilling to have combination chemotherapy
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver, and kidney function as defined by specific lab values
- INR less than 1.5 x ULN and PTT less than 1.5 x ULN if not on anticoagulation; stable anticoagulation if applicable
- For females of childbearing potential, negative pregnancy test within 14 days before randomization and agreement to use effective contraception or abstain during treatment and for 6 months after
- For men, agreement to use effective contraception or abstain during treatment and for 6 months after, and to avoid sperm donation
You will not qualify if you...
- Prior systemic therapy for metastatic disease; prior adjuvant chemotherapy allowed if completed more than 3 months before randomization
- Known brain metastases or symptoms suggesting brain metastases without ruling out by imaging
- Significant cardiovascular disease including recent heart attack, unstable angina, or severe heart failure
- Recent transient ischemic attack, cerebrovascular accident, or history of cerebral/aortic aneurysm or dissection
- Recent deep vein thrombosis or pulmonary embolism within 6 months or recurrent thromboembolic events within 2 years
- Severe bleeding events within last 6 months except surgically treated tumor bleeding
- Evidence of bleeding disorders or significant coagulopathy
- Uncontrolled hypertension despite medication
- Severe chronic wounds, ulcers, or untreated bone fractures
- History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
- Acute or subacute bowel obstruction, active chronic inflammatory bowel disease, or chronic diarrhea
- History of severe eye conditions like keratitis or severe dry eye
- Known hypersensitivity to study drugs or related products
- Recent or anticipated use of certain blood-thinning medications exceeding specified doses
- Recent major surgery or significant trauma within 28 days prior to randomization
- Recent core biopsy or minor surgery within 3 days prior to first dose of bevacizumab
- History or evidence of lung diseases such as pulmonary fibrosis or pneumonitis
- Other medical conditions that increase risk or affect study results
- History of other cancers unless disease-free for at least 3 years or specific exceptions
- Known alcohol or drug abuse
- Pregnant or breastfeeding women
- Participation in another clinical trial or experimental treatment within specified time frames
- Legal or institutional restrictions on patient participation
- Close relation to the investigator or limited legal capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
D
Dominik Paul Modest, Prof.
CONTACT
S
Sebastian Stintzing, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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