A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is
refractory to an initial chemotherapy regimen that included a platinum agent plus
paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian
tube cancer Initial response to platinum and paclitaxel must have been one of the
following: Progression or stable disease Response that lasted less than 3 months Response
that lasted at least 3 months, but when retreated with both agents (in combination or as
single agents) disease was refractory Measurable or evaluable disease Evaluable disease is
defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from
baseline determination

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal
(ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial
infarction within last 6 months No congestive heart failure No unstable angina No
clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral
neuropathy of any etiology that is greater than grade 1 Other: No active serious infection
or other serious underlying medical condition No prior significant allergic reactions to
drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or
nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No
concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been
administered on a 3 week or greater schedule No other prior chemotherapy besides platinum
and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least
3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3
weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At
least 3 weeks since major surgery