Colorectal Cancer
Conditions
Keywords
colorectal cancer
Brief summary
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
Detailed description
26 patients with advanced colorectal cancer will be given Bevacizumab at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression
Interventions
BIOLOGICALintervention
Sponsors
Rhode Island Hospital
The Miriam Hospital
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease. 2. Patients must not have had disease progression while receiving a minimum of 6 treatments of FOLFOX/bevacizumab. Patients with stable or responding disease on FOLFOX/bevacizumab are eligible. Bevacizumab does not need to be administered with all cycles of FOLFOX. 3. At least 3 weeks since prior FOLFOX/bevacizumab. 4. Wild type ras 5. No potentially curative treatment option. 6. ECOG performance status 0-1 7. Age\>18, not pregnant or breast-feeding 8. Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500/µl; platelet count ≥ 100,000/µl, Creatinine ≤ 2.0 mg/dl, Bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x upper limit of normal (or ≤ 5 x upper limit of normal for patients with liver metastases), Magnesium \> lower limit of normal 9. Life expectancy of at least 16 weeks 10. Must not have uncontrolled severe, intercurrent illness. 11. No chemotherapy or radiation therapy within last 3 weeks 12. No concurrent anticancer therapy. 13. Signed study-specific consent form prior to study entry
Exclusion criteria
1. Prior EGFR inhibitor and prior irinotecan. 2. Clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of \>150/90 mmHg on medication\], history of myocardial infarction within 6 months,), New York Heart Association (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia. Patients with an atrial arrhythmia must have this condition well controlled on stable medication. Patients with current or recent (within 6 months) unstable angina are also not eligible. 3. Significant bleeding diathesis or coagulopathy 4. Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed. 5. Serious, nonhealing wound, ulcer, or current healing fracture 6. History of cerebral aneurysms or cerebral arteriovenous malformations. 7. Patients with recent (within 12 months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), or clinically significant peripheral artery disease should also be excluded. 8. Brain metastases 9. Patients with a history of a gastrointestinal fistula or perforation. 10. Significant infection or other coexistent medical condition that would preclude protocol therapy. 11. Interstitial lung disease 12. Patients who have had an organ transplant 13. Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active hepatitis B infection 14. Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 15. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, bladder and cervix are permissible).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab | every 3 weeks until patient comes off study (progressive disease), for up to 2 years | To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3 |
Countries
United States
Participant flow
Recruitment details
5 Patients were enrolled at The Miriam and Rhode Island Hospital
Participants by arm
| Arm | Count |
|---|---|
| Intervention Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3
Time frame: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panitumumab and Bevacizumab | Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab | 1 participants |