Panitumumab and Gemcitabine in Relapsed Ovarian Cancer (PanGem)

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian cancer, platinum-refractory ovarian cancer Read More

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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