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

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Androgen-independent Prostate Cancer

Intervention: Erbitux (cetuximab) and Novantrone (mitoxantrone) (Drug); Novantrone (mitoxantrone) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Mark T. Fleming, MD, Principal Investigator, Affiliation: Virginia Oncology Associates/US Oncology

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.

Clinical Details

Official title: A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Time to radiographically evident disease progression, response rate in measurable disease, time to PSA, PSA response rate, PSA doubling time, overall survival, response rate attributable to the addition of Erbitux and Novatrone

Detailed description: This is a nonblinded, randomized phase II study to determine the activity of Novantrone (mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab) combination in this setting. Patients will be randomly assigned 2: 1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47 patients in Arm 2. A balanced randomization procedure will be performed utilizing a code list that will be developed prior to the study opening. Because the patients will be stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to ensure a balance between the 2 treatment arms.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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

- Agree to use contraceptives while on study if sexually active, and for 2 months after

the last dose of study drug.

- Has signed a Patient Informed Consent Form

- Has signed a Patient Authorization Form

Exclusion Criteria:

- 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

Locations and Contacts

Hematology Oncology Associates, Phoenix, Arizona 85012, United States

Northern AZ Hematology & Oncology Assoc, Sedona, Arizona 86336, United States

Rocky Mountain Cancer Center-Midtown, Denver, Colorado 80218, United States

Melbourne Internal Medicine Associates, Melbourne, Florida 32901, United States

Florida Cancer Institute - New Hope, New Port Richey, Florida 34655, United States

Ocala Oncology Center, Ocala, Florida 34474, United States

Cancer Centers of Florida, P.A., Ocoee, Florida 34761, United States

Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois 60714, United States

Central Indiana Cancer Centers, Indianapolis, Indiana 46277, United States

Hope Center, Terre Haute, Indiana 47802, United States

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota 55404, United States

Missouri Cancer Associates, Columbia, Missouri 65201, United States

St. Joseph Oncology, Inc., St. Joseph, Missouri 64507, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89169, United States

NH Oncology-Hematology PA, Hooksett, New Hampshire 03106, United States

Hematology-Oncology Associates of NNJ, P, Morristown, New Jersey 07960, United States

Albany Medical Cancer Center, Albany, New York 12208, United States

Interlakes Oncology Hematology, PC, Rochester, New York 14623, United States

Cancer Centers of North Carolina, Raleigh, North Carolina 27607, United States

Greater Dayton Cancer Center, Kettering, Ohio 45409, United States

Willamette Valley Cancer Center, Eugene, Oregon 97401, United States

Oregon Health & Science University, Portland, Oregon 97239, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29605, United States

Texas Oncology, P.A. -Amarillo, Amarillo, Texas 79106, United States

Texas Oncology, P.A., Arlington, Texas 76012, United States

Texas Oncology - Central Austin Cancer Center, Austin, Texas 78731, United States

Mamie McFaddin Ward Cancer Center, Beaumont, Texas 77702, United States

Methodist Charlton Cancer Ctr., Dallas, Texas 75237, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230, United States

Texas Oncology, P.A., Dallas, Texas 75231, United States

Texas Oncology, P.A., Dallas, Texas 75246, United States

Texas Cancer Center, Denton, Texas 76210, United States

El Paso Cancer Treatment Ctr, El Paso, Texas 79915, United States

Texas Oncology, P.A., Ft. Worth, Texas 76104, United States

Texas Oncology, P.A, Garland, Texas 75042, United States

Longview Cancer Center, Longview, Texas 75601, United States

South Texas Cancer Center - McAllen, McAllen, Texas 78503, United States

Texas Cancer Center of Mesquite, Mesquite, Texas 75150, United States

Allison Cancer Center, Midland, Texas 79701, United States

Texas Oncology - Odessa, Odessa, Texas 79761, United States

Paris Regional Cancer Center, Paris, Texas 75460, United States

Texas Cancer Center - Sherman, Sherman, Texas 75090, United States

Texas Oncology Cancer Center-Sugar Land, Sugar Land, Texas 77479, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Texas Oncology, P.A., Webster, Texas 77598, United States

Fairfax Northern VA Hem-Onc PC, Fairfax, Virginia 22031, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Onc and Hem Associates of SW VA, Inc., Salem, Virginia 24153, United States

Highline Medical Oncology, Burien, Washington 98166, United States

Puget Sound Cancer Center-Edmonds, Edmonds, Washington 98026, United States

Columbia Basin Hematology and Oncology, Kennewick, Washington 99336, United States

Puget Sound Cancer Center-Seattle, Seattle, Washington 98133, United States

Cancer Care Northwest-South, Spokane, Washington 99202, United States

Northwest Cancer Specialists-Vancouver, Vancouver, Washington 98684, United States

Yakima Valley Mem Hosp/North Star Lodge, Yakima, Washington 98902, United States

Additional Information

Starting date: May 2008
Last updated: April 6, 2010

Page last updated: August 23, 2015

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