A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced ovarian
epithelial cancer, fallopian tube cancer, or primary peritoneal cancer Serous papillary
Endometrioid Mucinous Clear cell Poorly differentiated adenocarcinomas Mixture of any of
the above histologies No sarcomatous, stromal, or germ cell elements Measurable disease by
radiological imaging with progression in the past 3 months or no response to prior therapy
The following are not considered measurable: Pleural effusions Ascites Osseous metastases
CA-125 tumor markers Lesions in previously irradiated areas Platinum resistant or
refractory Less than 6 month treatment-free interval after platinum-containing regimen OR
Progression during platinum-based therapy No leptomeningeal or carcinomatous meningitis
Known CNS metastases allowed if patient is previously treated, neurologically stable, has
no evidence of active disease by CT or MRI, and has no requirement for therapy with oral
or IV steroids or anticonvulsants

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.5
mg/dL ALT and AST no greater than 3.0 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No gross hematuria
Cardiovascular: No uncontrolled cardiac arrhythmia No myocardial infarction within the
past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception during and for at least 6 months after study No unstable
medical conditions No severe concurrent disease or infection that would preclude study No
intestinal obstruction interfering with nutrition No psychiatric disorders that would
preclude study No other prior malignancy within the past 5 years except adequately treated
carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered At least 2 weeks since prior prophylactic filgrastim (G-CSF) or sargramostim
(GM-CSF) No concurrent immunotherapy No concurrent biological response modifiers
Chemotherapy: See Disease Characteristics At least 1 but no more than 3 prior chemotherapy
regimens (platinum-containing regimens count as 1 regimen) At least 4 weeks since prior
chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks
since prior radiotherapy or radiopharmaceuticals and recovered No prior radiotherapy to
whole pelvis No concurrent radiotherapy including palliative radiotherapy (except local
radiotherapy for pain or solitary brain metastasis if not progressing systemically)
Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days
since prior investigational drugs No other concurrent investigational agents