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 6-hydroxymethylacylfulvene in treating patients who have stage IVB or recurrent cervical cancer.

Condition	Treatment or Intervention	Phase
recurrent cervical cancer cervical adenocarcinoma cervical squamous cell carcinoma cervical adenosquamous cell carcinoma stage IVB cervical cancer	Drug: -hydroxymethylacylfulvene	Phase II

OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene in patients with stage IVB or recurrent cervical carcinoma.

II. Determine the safety of this drug in this patient population.

PROTOCOL OUTLINE: Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 consecutive days. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Criteria

PROTOCOL ENTRY 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

--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

--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

Study chairs or principal investigators

Carol Aghajanian,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067675; MSKCC-99072; NCI-T99-0096
Record last reviewed:  August 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005070
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20