A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

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