Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)

NCT00661492 | Completed Phase 2 Results

• 1 other identifier: 06-118
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 55

Brief Summary

To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.

Conditions

Androgen-independent Prostate Cancer

Keywords

Androgen-independent prostate cancer(AIPC)

Outcome Measures

Primary Outcomes (1)

• Median Time to Progression (TTP)

  TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.

  24 months

Secondary Outcomes (7)

• 2-year Radiographically Evident Progression-free Survival (REPFS).

  24 months.

• Objective Response Rate (ORR)

  24 months

• Median Time to Prostate-specific Antigen (PSA) Progression

  24 months

• Prostate-specific Antigen (PSA) Response Rate

  24 months

• Prostate-specific Antigen (PSA) Doubling Time

  24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Erbitux (cetuximab) and Novantrone (mitoxantrone)

Drug: cetuximab; Drug: Mitoxantrone

Arm 2

EXPERIMENTAL

Novantrone (mitoxantrone)

Drug: Mitoxantrone

Interventions

cetuximab DRUG

Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter

Also known as: Erbitux

Arm 1

Mitoxantrone DRUG

Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists

Also known as: Novantrone

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate. Note: Patients may have either measurable or non-measurable disease.
• Radiographic evidence of regional or distant metastases
• Current evidence of progression (by PSA and/or imaging studies) despite standard hormonal therapy.
• Progression by PSA will be defined as: A rising PSA defined as: at least 2 rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least 1 week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2. Progression for nonmeasurable disease will be defined as 2 or more new bone lesions; for measurable disease, progression will be defined by standard RECIST criteria.
• For patients who have been on antiandrogen therapy (ie, bicalutamide, flutamide, etc.), patients must have discontinued anti-androgen therapy for at least 6 weeks (4 weeks for flutamide) without evidence of an antiandrogen withdrawal response. A washout period will not be required for patients who did not respond to an antiandrogen prescribed as second line hormonal therapy. For patients whose progression is documented by PSA, the last required PSA must be after the required anti-androgen washout period (4-6 weeks as appropriate).
• One prior docetaxel-containing regimen. Patients must have received at least 2 doses in an every 3-week schedule or 6 doses on a weekly schedule of docetaxel. Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons. Chemotherapy treatment with any second-line regimen will not be permitted. Patients who have been previously treated with a first-line docetaxel-based doublet regimen will be eligible for this study, (eg, patients treated on a prior first-line trial containing a docetaxel/carboplatin or other docetaxel-based doublet).
• Serum testosterone levels (See protocol for specific details) (unless surgically castrate). Patients must continue androgen deprivation with an LHRH agonist if they have not undergone orchiectomy
• ECOG performance status
• Laboratory criteria for entry:
• absolute neutrophil count
• platelets
• bilirubin
• AST or ALT
• Life expectancy greater than 3 months
• Age greater than or equal to 18 years

You may not qualify if:

• More than 1 prior chemotherapy regimen for metastatic disease
• Prior history of uncontrolled congestive heart failure or left ventricular ejection fraction (LVEF) that is less than the institution's lower limit of normal on MUGA or echocardiogram
• A second active malignancy (diagnosed within 5 years) except adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
• Significant active concurrent medical illness or infection
• Treatment with chemotherapy for AIPC within the past 21 days
• Prior treatment with Novantrone (mitoxantrone)
• Prior therapy which specifically and directly targets the EGFR pathway
• Prior severe infusion reaction to a monoclonal antibody
• Recent myocardial infarction (within prior 6 months)
• Prior treatment with radionuclides, with the exception of prior treatment with samarium, which will be allowed provided at least 8 weeks have passed since administration.
• Is receiving concurrent immunotherapy, hormonal therapy, radiation therapy, or any other non-protocol therapy (excluding LHRH antagonist)
• Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
• Has evidence of CNS involvement
• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
• Is unable to comply with requirements of study

Sponsors & Collaborators

• US Oncology Research: lead
• Eli Lilly and Company: collaborator
• Oregon Health and Science University: collaborator

Study Sites (55)

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Northern AZ Hematology & Oncology Assoc

Sedona, Arizona, 86336, United States

Location

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, 80218, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Florida Cancer Institute - New Hope

New Port Richey, Florida, 34655, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46277, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

NH Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

Hematology-Oncology Associates of NNJ, P

Morristown, New Jersey, 07960, United States

Location

Albany Medical Cancer Center

Albany, New York, 12208, United States

Location

Interlakes Oncology Hematology, PC

Rochester, New York, 14623, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Oncology, P.A. -Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology, P.A.

Arlington, Texas, 76012, United States

Location

Texas Oncology - Central Austin Cancer Center

Austin, Texas, 78731, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75231, United States

Location

Methodist Charlton Cancer Ctr.

Dallas, Texas, 75237, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, P.A

Garland, Texas, 75042, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

South Texas Cancer Center - McAllen

McAllen, Texas, 78503, United States

Location

Texas Cancer Center of Mesquite

Mesquite, Texas, 75150, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology - Odessa

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology, P.A.

Webster, Texas, 77598, United States

Location

Fairfax Northern VA Hem-Onc PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Onc and Hem Associates of SW VA, Inc.

Salem, Virginia, 24153, United States

Location

Highline Medical Oncology

Burien, Washington, 98166, United States

Location

Puget Sound Cancer Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Columbia Basin Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Puget Sound Cancer Center-Seattle

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest-South

Spokane, Washington, 99202, United States

Location

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, 98684, United States

Location

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, 98902, United States

Location

Related Publications (1)

• Fleming MT, Sonpavde G, Kolodziej M, Awasthi S, Hutson TE, Martincic D, Rastogi A, Rousey SR, Weinstein RE, Galsky MD, Berry WR, Wang Y, Boehm KA, Asmar L, Rauch MA, Beer TM. Association of rash with outcomes in a randomized phase II trial evaluating cetuximab in combination with mitoxantrone plus prednisone after docetaxel for metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2012 Mar;10(1):6-14. doi: 10.1016/j.clgc.2011.11.003.

  PMID: 22340631 DERIVED

MeSH Terms

Interventions

Cetuximab; Mitoxantrone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Mark T. Fleming
• Organization: US Oncology

Mark.Fleming@USONCOLOGY.COM

757-827-9400

Study Officials

• Mark T. Fleming, MD

  Virginia Oncology Associates/US Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 18, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 9, 2016
• Results First Posted: December 9, 2016

Record last verified: 2016-10

Locations

US (55)