A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix
not curable by surgery or radiotherapy

- Measurable disease

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if
liver metastases present)

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No active congestive heart failure

- No uncontrolled angina

- No myocardial infarction within the past 6 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent serious infection

- No other malignancy within the past 5 years except nonmelanomatous skin cancer

- No other life threatening illness

- No psychosis, mental disability, or incompetence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent biologic therapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy

- No more than 1 prior chemotherapy regimen (except chemotherapy for
radiosensitization)

- No prior camptothecin

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- At least 4 weeks since prior surgery

- No concurrent surgery

Other:

- At least 4 weeks since other prior investigational drugs (including analgesics or
antiemetics)

- No other concurrent investigational drugs during or within 28 days after final dose
of study drug

- No concurrent drugs that induce or inhibit CYP3A enzyme