Panitumumab and Gemcitabine in Relapsed Ovarian Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic, advanced, or recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
* Prior first line therapy with a platinum and taxane based combination as adjuvant therapy
* Measurable disease defined by RECIST criteria
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* age \> 18
* Karnofsky performance status \> 70
* Up to three prior lines of cytotoxic therapy in the setting of recurrent disease.
* Estimated life expectancy of at least 3 months
* Women of child-bearing potential must have a negative pregnancy test
* Adequate hematopoietic function defined as:

  * ANC ≥ 1500/mm3
  * Platelets ≥ 100,000/mm3
  * Hemoglobin ≥ 9 g/dL
  * Magnesium ≥ lower limit of normal
  * Calcium ≥ lower limit of normal
* Adequate renal and hepatic function defined as:

  * Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  * SGOT ≤ 3 times ULN
  * Alanine aminotransferase (ALT) ≤3xULN (if liver metastases ≤5xULN)
  * Alkaline phosphatase ≤ 3 times ULN
  * Creatinine ≤ 1.5 mg/dL times ULN
  * Creatinine clearance ≤ 50 mL/min

Exclusion Criteria:

* Prior anti-EGFr antibody therapy (e.g., cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib)
* Prior treatment with gemcitabine
* Radiotherapy ≤ 14 days prior to enrollment.
* More than three lines of systemic chemotherapy for recurrent or advanced disease. Prior hormonal therapy is allowed.
* Prior immunotherapy, or experimental or approved proteins/antibodies
* Female subject is pregnant or breast-feeding.
* Patient has received other investigational drugs within 28 days before enrollment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Prior treatment with panitumumab
* Concurrent uncontrolled illness
* Ongoing or active infection
* History or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers, curatively resected non-melanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance.
* History or known presence of central nervous system (CNS) metastasis
* Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine)
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 1 year before randomization
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
* Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
* Major surgery within 28 days or minor surgery within 14 days of study enrollment