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

Completed · Phase 2

Conditions studied: Androgen-independent Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00661492

Run by

US Oncology Research

People needed

115

Starts

2008-05-01

Expected to finish

2011-06-01

Last updated by the study team

2016-12-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• Northern AZ Hematology & Oncology Assoc — Sedona, Arizona, United States
• Rocky Mountain Cancer Center-Midtown — Denver, Colorado, United States
• Melbourne Internal Medicine Associates — Melbourne, Florida, United States
• Florida Cancer Institute - New Hope — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• Cancer Care & Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• Hope Center — Terre Haute, Indiana, United States
• Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• St. Joseph Oncology, Inc. — Saint Joseph, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• NH Oncology-Hematology PA — Hooksett, New Hampshire, United States
• Hematology-Oncology Associates of NNJ, P — Morristown, New Jersey, United States
• Albany Medical Cancer Center — Albany, New York, United States
• Interlakes Oncology Hematology, PC — Rochester, New York, United States
• Cancer Centers of North Carolina — Raleigh, North Carolina, United States
• Greater Dayton Cancer Center — Kettering, Ohio, United States
• Willamette Valley Cancer Center — Eugene, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Texas Oncology, P.A. -Amarillo — Amarillo, Texas, United States
• Texas Oncology, P.A. — Arlington, Texas, United States
• Hematology Oncology Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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