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: June 18, 2014
Last verified: June 2014
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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||June 18, 2014
||United States: Food and Drug Administration
Keywords provided by Brown University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Angiogenesis Modulating Agents
Physiological Effects of Drugs