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

Phase 2
18 Years
Open (Enrolling)
Androgen-independent Prostate Cancer

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

approximately 2 years

Safety Issue:


Principal Investigator

Mark T. Fleming, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Oncology Associates/US Oncology


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

May 2010

Related Keywords:

  • Androgen-independent Prostate Cancer
  • Androgen-independent prostate cancer(AIPC)
  • Prostatic Neoplasms



Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Tyler Cancer CenterTyler, Texas  75702
Oregon Health & Science UniversityPortland, Oregon  97201
Hope CenterTerre Haute, Indiana  47809
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Cancer Centers of Florida, P.A.Orlando, Florida  
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
Highline Medical OncologyBurien, Washington  98166
Hematology Oncology AssociatesPhoenix, Arizona  85012
Greater Dayton Cancer CenterKettering, Ohio  45409
Texas Cancer CenterAbilene, Texas  79606
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Onc and Hem Associates of SW VA, Inc.Salem, Virginia  24153
Texas Oncology, P.AArlington, Texas  76012
South Texas Cancer Center - McAllenMcAllen, Texas  78503-1298
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Texas Oncology - Central Austin Cancer CenterAustin, Texas  78731
Northern AZ Hematology & Oncology AssocSedona, Arizona  86336
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
NH Oncology-Hematology PAHooksett, New Hampshire  03106
Interlakes Oncology Hematology, PCRochester, New York  14623
El Paso Cancer Treatment CtrEl Paso, Texas  79915
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Puget Sound Cancer Center-SeattleSeattle, Washington  98133
Cancer Care Northwest-SouthSpokane, Washington  99202
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Fairfax Northern VA Hem-Onc PCFairfax, Virginia  22031
Puget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Florida Cancer Institute - New HopeNew Port Richey, Florida  34655
Methodist Charlton Cancer Ctr.Dallas, Texas  75237
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Texas Oncology - OdessaOdessa, Texas  79761
Hematology-Oncology Associates of NNJ, PMorristown, New Jersey  07960
Albany Medical Cancer CenterAlbany, New York  12208
Texas Oncology, P.A. -AmarilloAmarillo, Texas  79106