Overview

Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
0
Participant gender:
Female
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IVB or recurrent cervical cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Irofulven
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