NCT00058552

Who might be able to join this trial:

• You are willing to sign a consent form agreeing to take part in the study
• You are willing to have a tumor biopsy taken, and your tumor is in a location that can be safely biopsied (first group of participants only)
• You are 18 years of age or older
• You have been diagnosed with advanced ovarian cancer confirmed by laboratory tissue testing
• You have measurable tumors — either at least one tumor large enough to be measured by standard scans (at least 20mm on regular scans, or at least 10mm on a spiral CT scan), OR you have disease visible on scans or exams (such as fluid buildup or deposits) along with two blood test results (CA-125) taken at least one week apart showing levels more than twice the lab's upper normal limit and at least 40 IU/mL
• You have previously received at least one chemotherapy treatment containing a platinum-based drug (such as carboplatin or cisplatin) for your ovarian cancer
• Doctors expect you to live for at least 12 weeks or more
• You are generally able to carry out daily activities with little or no difficulty (confirm with trial site regarding the specific activity scale used)
• You are using effective birth control if there is any chance you could become pregnant
• Your blood counts are at acceptable levels — enough white blood cells, platelets, and red blood cells (transfusions or growth factor support are allowed to meet this requirement)
• Your liver function blood tests are within acceptable ranges
• Your kidney function blood test is within an acceptable range
• Your blood clotting tests are within acceptable ranges (unless you are already taking warfarin)

Who may not be able to join:

• You have received any experimental cancer treatment within the 4 weeks before the first dose of the study drug
• You have ever been treated with certain drugs that target a specific cancer pathway called HER, such as Herceptin (trastuzumab), Iressa, or Tarceva
• You have a history of cancer that has spread to your brain or spinal fluid
• Your heart's pumping function (ejection fraction) is below 50% on an echocardiogram (heart ultrasound)
• You have uncontrolled high calcium levels in your blood
• You have previously received high cumulative doses of certain chemotherapy drugs including doxorubicin, liposomal doxorubicin, mitoxantrone, or idarubicin (confirm specific limits with trial site)
• You have been diagnosed with another cancer within the past 5 years, except for certain early-stage or skin cancers that have been fully treated (such as cervical carcinoma in situ, ductal carcinoma in situ of the breast, or basal/squamous cell skin cancer)
• You have serious ongoing health conditions such as an active infection, poorly controlled high blood pressure, unstable chest pain, heart failure, or a heart attack within the past 6 months, or an uncontrolled irregular heartbeat requiring medication
• You have active liver disease, including hepatitis, current alcohol misuse, or cirrhosis
• You have a known HIV infection
• You are currently pregnant or breastfeeding
• You have had major surgery or a serious injury within the 3 weeks before starting the study (except for a biopsy done as part of this study)
• You are unable or unwilling to follow the study schedule and attend follow-up visits
• You have any other significant health condition, abnormal test result, or finding that the doctors feel could make it unsafe for you to participate or could affect the study results

Important: Always verify eligibility with the trial site directly before applying.