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

NCT00996502 | Terminated Phase 1 Results DMC

• 1 other identifier: AAAB8399
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I)

  After three 21-day cycles

Secondary Outcomes (3)

• Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone

  Every 9 weeks

• Overall Survival Rate

  2 years

• Proportion of Patients Alive at One Year (Phase II)

  One year

Study Arms (1)

Combination regimen

EXPERIMENTAL

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; Drug: Bevacizumab; Drug: Erlotinib; Drug: Prednisone

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

Combination regimen

Bevacizumab DRUG

15mg/kg of Bevacizumab every 3 weeks

Also known as: Avastin

Combination regimen

Erlotinib DRUG

200 mg of Erlotinib PO daily days 2-16

Also known as: Tarceva

Combination regimen

Prednisone DRUG

5 mg of Prednisone PO bid

Also known as: Prednicot

Combination regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Bevacizumab; Erlotinib Hydrochloride; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: CU PRS Administrator
• Organization: Columbia University

ClinicalTrialsGov@cumc.columbia.edu

212-342-1643

Study Officials

• Daniel P Petrylak, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 16, 2009
• Study Start: July 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 27, 2019
• Results First Posted: March 25, 2016

Record last verified: 2019-03

Locations

US (1)