Panitumumab and Gemcitabine in Relapsed Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Panitumumab
Intervention description: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent ovarian cancer; platinum-refractory ovarian cancer

Summary:

      This is a study to find out if the study drug, panitumumab, when given with gemcitabine works
      in treating ovarian cancer and to find out what side effects occur when they are given
      together.
    

Eligibility criteria:

        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             not part of normal medical care, with the understanding that consent may be withdrawn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