Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Topotecan; Erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chemotherapy; combination therapy; targeted therapy; second-line

Summary:

      This is a single arm phase II study with a combination of Hycamptin® (topotecan) and
      erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent
      ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30
      patients will be enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically proven, previously treated, epithelial ovarian cancer,
             and/or serous ovarian cancer.

          2. Evaluable disease with CA125 levels two times the upper limit of normal for the
             institution (>50u/ml ) on two occasions at least one week apart is required in order
             to apply CA-125 response criteria.

          3. Previously treated for ovarian cancer with a taxane and platinum based regimen. and an
             additional topotecan regimen (any number of chemotherapy or biologic therapies are
             allowed; including prior erlotinib are allowed)

          4. Age >= 18 years.

          5. Minimum life expectancy: 4 months.

          6. ECOG (Eastern Cooperative Oncology Group) performance status 0,1, or 2. 0: Fully
             active, unrestricted activities of daily living. 1: Ambulatory, but restricted in
             strenuous activity. 2: Ambulatory, and capable of self care. Unable to work. Out of
             bed for greater than 50% of waking hours.

          7. Complete blood count (CBC) performed less than seven days prior to enrollment and have
             an absolute neutrophil count >1.0 X 10^9/L, and a platelet count >100 X 10^9/L.

          8. Serum chemistry panel drawn less than seven days prior to enrollment and have a total
             bilirubin <= 1.5 X the institutional upper limit of normal (IULN), or SGOT/AST is <
             2.5 X IULN.

          9. Serum creatinine <= 1.5 X institutional upper limit of normal (IULN). If the serum
             creatinine level is >= 1.5 IULN, but the serum creatinine clearance >= 50 mg/dL, then
             the subject can enter the study.

         10. Central line access.

         11. Signed written informed consent (approved by the Institutional Review Board
             [IRB]/Ethics Committee) obtained prior to study entry.

        Exclusion Criteria:

        If the answer to any of the exclusion criteria is YES, the subject is NOT ELIGIBLE for the
        study.

          1. Presence of active cancer other than that described in Section 3.1.criteria (a), with
             the exception of a diagnosis of synchronous occurrence of adenocarcinoma in ovary and
             uterus.

          2. Uncontrolled intercurrent illness not limited to infection, symptomatic congestive
             heart failure, or unstable angina pectoris, or cardiac arrhythmia.

          3. Acute toxicity of prior chemotherapy is still present

          4. History of severe allergic reaction to erlotinib

          5. Unresolved sequelae resulting from any surgical procedures.

          6. Symptomatic, untreated brain metastases. Patients with untreated brain metastases
             should be excluded from this clinical trial because of their poor prognosis and
             because they often develop progressive neurologic dysfunction that would confound the
             evaluation of neurologic and other adverse events.

          7. Lactating or pregnant. The investigational agent topotecan may be toxic to the
             developing fetus or nursing infant and poses unknown health risks. Documentation of a
             negative, serum HCG pregnancy test is required for women of child bearing potential
             (WOCBP) within 2 weeks prior to the start of treatment. WOCBP is defined as women who
             have not been naturally postmenopausal for at least 12 consecutive months or no
             previous surgical sterilization. A negative pregnancy test within 2 weeks prior to
             start of treatment is required.

          8. Women of childbearing potential must use effective contraception throughout the time
             they are on study. Before entering this trial, patients must be made aware of the risk
             in becoming pregnant.

          9. Receipt of any investigational drug within 28 days before beginning treatment with
             study drug and/or concomitant treatment with other investigational agents.

         10. Patients with a history of poorly controlled gastrointestinal disorders that could
             affect absorption of erlotinib (e.g. Crohn's, ulcerative colitis, etc)