Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
Condition: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial; Peritoneal Neoplasms
Intervention: gemcitabine hydrochloride; tanespimycin
Intervention description: Given IV; Given IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in
      treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity
      cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work
      in different ways to stop tumor cells from dividing so they stop growing or die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ovarian epithelial or primary peritoneal cavity cancer

               -  Relapsed disease

               -  Persistent disease

          -  Platinum-resistant disease, defined as having evidence of disease that would be
             expected to be non-responsive to additional platinum-containing regimens or
             contraindication to platinum-based chemotherapy and 1 of the following:

               -  Failure to obtain a complete response to initial platinum therapy

               -  Recurrence < 6 months after completing a platinum-containing regimen for initial
                  or recurrent disease

               -  Any of the above situations and following treatment with additional chemotherapy
                  regimens (e.g., non-platinum containing regimens)

               -  Relative or absolute contraindication to platinum-based chemotherapy regimens
                  (e.g., platinum allergy) as determine by the investigator

          -  Measurable or evaluable disease

               -  Patients with a rising CA 125 level, even in the absence of other indicators of
                  disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)

          -  Patients with accessible disease must be willing to undergo tumor biopsies

          -  No CNS metastases

          -  Performance status - ECOG 0-2

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Bilirubin normal

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  AST ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy

          -  No significant cardiac disease including any of the following:

               -  New York Heart Association class III or IV heart disease

               -  History of myocardial infraction within the past year

               -  Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs

               -  Poorly controlled angina

          -  No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or
             ventricular fibrillation ≥ 3 beats in a row)

          -  No history of QTc ≥ 500 msec

          -  No active ischemic heart disease within the past 12 months

          -  No congenital long QT syndrome

          -  No left bundle branch block

          -  No cardiac symptoms ≥ grade 2

          -  No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin
             hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)

          -  Does not meet the medicare criteria for home oxygen

          -  No pulse oximetry at rest and exercise < 88%

          -  No symptomatic pulmonary disease requiring medication including any of the following:

               -  Dyspnea on or off exertion

               -  Paroxysmal nocturnal dyspnea

               -  Oxygen requirement

               -  Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary
                  disease)

          -  No pulmonary symptoms ≥ grade 2

          -  No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin
             hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)

          -  K+, Mg ++, and Ca ++ normal

          -  No seizure disorder

          -  No uncontrolled infection

          -  No history of serious allergic reaction to eggs

          -  More than 4 weeks since prior immunotherapy

          -  More than 4 weeks since prior biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim
             [G-CSF] or sargramostim [GM-CSF])

          -  See Disease Characteristics

          -  More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
             recovered

          -  Prior gemcitabine hydrochloride allowed provided 1 of the following criteria is met:

               -  Patients have no prior exposure to gemcitabine hydrochloride

               -  Patients who have prior exposure to gemcitabine hydrochloride as a single agent
                  have experienced progressive disease while on treatment

          -  No other concurrent chemotherapy

          -  No prior radiotherapy to > 25% of bone marrow

          -  No history of radiotherapy that potentially included the heart in the field (e.g.,
             mantle)

               -  Chest wall irradiation or other radiotherapy techniques that do not include the
                  heart in the radiation field area allowed

          -  More than 4 weeks since prior radiotherapy

          -  More than 4 weeks since prior radiopharmaceuticals

          -  No concurrent radiotherapy

          -  No other concurrent investigational therapy

          -  No concurrent medications that may prolong QTc