A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IVB or recurrent cervical carcinoma that is not
amenable to standard curative therapies
- Squamous carcinoma OR
- Adenocarcinoma
- Measurable disease
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- Nonmeasurable disease defined as any of the following:
- Bone disease
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed or followed by imaging techniques
- Cystic lesions
- No active brain metastases
PATIENT CHARACTERISTICS:
Age:
- 17 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No cardiac arrhythmias, unstable angina, or conduction abnormalities
- No New York Heart Association class III or IV heart disease or clinical evidence of
congestive heart failure
- Pretreatment QTc less than 500 msec
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after study
- No grade 3 or greater neurologic abnormalities
- No history of seizures
- No concurrent uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than 2 prior therapies for advanced disease
Chemotherapy:
- No more than 2 prior therapies for advanced disease
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- No more than 2 prior therapies for advanced disease
Radiotherapy:
- No more than 2 prior therapies for advanced disease
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 4 weeks since prior cytotoxic therapy or investigational agents