Status:
TERMINATED
Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives of this study are to evaluate the safety and best dose of a regimen including bevacizumab and erlotinib in combination with docetaxel and prednisone. In addition, the investigat...
Detailed Description
In this Phase I/Phase II study, the primary objectives are to establish the maximum tolerated dose of docetaxel, erlotinib, bevacizumab, and prednisone in patients with metastatic hormone refractory p...
Eligibility Criteria
Inclusion
- Histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative therapy.
- Evidence of progressive metastatic disease.
- Surgically or medically castrated. Patients must continue on medical castration (LHRH agonists) throughout protocol participation. Patients who have discontinued LHRH agonists should be restarted on therapy. Testosterone levels should be obtained prior to protocol initiation and should be less than 50 ng/mL.
- Previous antiandrogen and hormonal therapies must have been discontinued prior to protocol initiation.
- Receiving bisphosphonate therapies should have had this therapy started at least 4 weeks prior to treatment initiation and should be on a stable dose. Although being on bisphosphonate therapy is not an exclusion to the study, bisphosphonate therapy should not be started during the study.
- Fully recovered and greater than 4 weeks from any major surgery or radiation therapy. There must be greater than 8 weeks from last dose of radionucleotide administration. There must be greater than 7 days from minor surgical procedures (eg portacath insertion, fine needle aspirations or core biopsies).
- No previous cytotoxic therapy including estramustine or suramin. No previous therapies with anti-angiogenic agents including thalidomide or bevacizumab.
- No history of brain metastases.
- No current congestive heart failure (defined as New York Heart Association Class II, III, or IV).
- Well-controlled blood pressure. Those with a history of hypertension should be well-controlled on a regimen of anti-hypertensive medication (exclude if BP\>150/100).
- No history of significant bleeding (e.g. upper or lower gastrointestinal bleeding or hemoptysis) within 6 months of protocol enrollment.
- No history of gastrointestinal perforation, intraabdominal fistula, or intraabdominal abscess within 6 months of protocol enrollment.
- No history of arterial thrombotic events within 6 months of protocol enrollment.
- No active serious non-healing wound, ulcer, or bone fracture.
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1.
- \> 18 years old.
- Adequate hematopoietic and organ function.
- Able to swallow capsules.
- Willing to use effective means of contraception for study duration and for at least 3 months after the completion of protocol therapy.
- Able to provide informed consent.
Exclusion
- Active second malignancy other than basal or squamous skin cancer. Patients who have completed all necessary therapy and are considered to have less than a 30% risk of relapse by their physician are not thought to have an active second malignancy.
- Serious concurrent uncontrolled medical disorder.
- Disease for whom corticosteroids are contraindicated such as an active peptic ulcer or uncontrolled diabetes. Patients with controlled diabetes may be considered but must be made aware that their diabetic medications may require adjustment.
- Received prior treatment with a tyrosine kinase inhibitor, estimated glomerular filtration rate inhibitor (EGFR), or vascular endothelial growth factor (VEGF) inhibitor. For the phase II trial, patients who have had previous cytotoxic therapy will not be eligible.
- Currently or have recently participated in a clinical trial (within 4 weeks from the first day of treatment) or are receiving investigational therapies.
- Unable to comply with study or follow-up procedures.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00996502
Start Date
July 1 2006
End Date
March 1 2010
Last Update
March 27 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032