Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
This study has been terminated.
(possible lack of efficacy)
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
First received: January 20, 2010
Last updated: October 9, 2013
Last verified: October 2013
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
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
- Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
- 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
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically or pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease.
- 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.
- At least 3 weeks since prior FOLFOX/bevacizumab.
- Wild type ras
- No potentially curative treatment option.
- ECOG performance status 0-1
- Age>18, not pregnant or breast-feeding
- 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
- Life expectancy of at least 16 weeks
- Must not have uncontrolled severe, intercurrent illness.
- No chemotherapy or radiation therapy within last 3 weeks
- No concurrent anticancer therapy.
- Signed study-specific consent form prior to study entry
- Prior EGFR inhibitor and prior irinotecan.
- 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.
- Significant bleeding diathesis or coagulopathy
- Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed.
- Serious, nonhealing wound, ulcer, or current healing fracture
- History of cerebral aneurysms or cerebral arteriovenous malformations.
- 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.
- Brain metastases
- Patients with a history of a gastrointestinal fistula or perforation.
- Significant infection or other coexistent medical condition that would preclude protocol therapy.
- Interstitial lung disease
- Patients who have had an organ transplant
- Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active hepatitis B infection
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057017
|Rhode Island Hospital
|Providence, Rhode Island, United States, 02906 |
Rhode Island Hospital
The Miriam Hospital
||howard p safran, MD
No publications provided
||howard safran, Director of BrUOG, Brown University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 20, 2010
|Results First Received:
||May 9, 2013
||October 9, 2013
||United States: Food and Drug Administration
Keywords provided by Brown University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs