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Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996502
Recruitment Status : Terminated (Poor enrollment; PI left the institution)
First Posted : October 16, 2009
Results First Posted : March 25, 2016
Last Update Posted : March 27, 2019
Genentech, Inc.
Information provided by (Responsible Party):
Columbia University

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 investigators wish to evaluate how well these drugs might work against this disease. Bevacizumab and erlotinib are novel drugs that attack the blood vessels supplying the tumor cells and attack a receptor on the tumor cells, respectively. This study has two parts. In the first part of the study, eighteen patients will be enrolled. Patients will receive escalating doses of docetaxel in combination with standard doses of bevacizumab and erlotinib until the safest dose is determined. An additional 37 patients will enter into the second part of the study and all will receive the safest dose. In this part of the study, the effectiveness of this regimen against hormone refractory prostate cancer (HRPC) will be monitored by evaluating prostate-specific antigen (PSA) and objective response of the tumor.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Bevacizumab Drug: Erlotinib Drug: Prednisone Phase 1 Phase 2

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 prostate cancer and to determine the efficacy of this regimen for treatment of metastatic HRPC. In the phase I portion of the study, eligible patients will be enrolled and treated using a "3+3" design. Docetaxel will be started at 55 mg/m2 every cycle (21 days) and dose escalated by 10 mg/m2 at each cohort level. The dose of bevacizumab will be held constant at 15 mg/kg every 3 weeks and erlotinib will be provided at 200 mg PO daily from days 216 as described in previous safety studies. All patients will receive prednisone 5 mg PO bid. Eighteen patients will be treated in the phase I portion. The phase II dose for this combined treatment will be defined as either the highest dosage cohort in which 6 patients are treated and there are less than 3 dose limiting toxicities (DLTs); or the combination of docetaxel, erlotinib, and bevacizumab at the cohort 3 dose level, whichever is the lower dose. Another 37 patients will be enrolled for the phase II study. All patients will receive the phase II recommended dose as determined by the phase I portion of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Bevacizumab and Erlotinib in Combination With Docetaxel and Prednisone for Patients With Hormone Refractory Prostate Cancer
Study Start Date : July 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Combination regimen

Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)

Phase I:

  • Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
  • Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
  • Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid
Drug: Docetaxel

Phase I:

  • Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle
  • Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle
  • Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle
Other Name: Taxotere

Drug: Bevacizumab
15mg/kg of Bevacizumab every 3 weeks
Other Name: Avastin

Drug: Erlotinib
200 mg of Erlotinib PO daily days 2-16
Other Name: Tarceva

Drug: Prednisone
5 mg of Prednisone PO bid
Other Name: Prednicot

Primary Outcome Measures :
  1. Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I) [ Time Frame: After three 21-day cycles ]

Secondary Outcome Measures :
  1. Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone [ Time Frame: Every 9 weeks ]
  2. Overall Survival Rate [ Time Frame: 2 years ]
  3. Proportion of Patients Alive at One Year (Phase II) [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996502

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Genentech, Inc.
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Principal Investigator: Daniel P Petrylak, MD Columbia University
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Responsible Party: Columbia University Identifier: NCT00996502    
Other Study ID Numbers: AAAB8399
First Posted: October 16, 2009    Key Record Dates
Results First Posted: March 25, 2016
Last Update Posted: March 27, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protein Kinase Inhibitors
Enzyme Inhibitors