Panitumumab and Gemcitabine in Relapsed 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.

Key Facts

Interventions

Conditions

Eligibility

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Outcome Measures

Locations