A Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Advanced Cervical Carcinoma
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary metastatic (stage IVB) or
recurrent cervical carcinoma not amenable to curative therapy Squamous Adenocarcinoma
Adenosquamous Bidimensionally measurable disease No active brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal ALT/AST no greater than 2.5
times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN (1.95
mg/dL at MSKCC) OR Creatinine clearance at least 50 mL/min Cardiovascular: No New York
Heart Association class III or IV congestive heart failure No ECG evidence of acute
ischemia No significant conduction abnormality (e.g., bifascicular block, 2nd or 3rd
degree AV blocks) Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception No other malignancy within the past 5 years and deemed
low risk for recurrence No other concurrent clinical circumstances that would compromise
safety or integrity of trial
PRIOR CONCURRENT THERAPY: Prior multimodality therapy at diagnosis allowed (i.e.,
concurrent chemotherapy and radiotherapy, neoadjuvant chemotherapy followed by surgery
and/or radiotherapy, adjuvant chemotherapy and/or radiotherapy following surgery, or
adjuvant chemotherapy following radiotherapy) Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy for metastatic or recurrent disease Endocrine therapy:
Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4
weeks since prior major surgery