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A Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Advanced Cervical Carcinoma

Phase 2
Not Enrolling
Cervical Cancer

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Trial Information

A Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Advanced Cervical Carcinoma

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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

May 2001

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms