Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005070
• Other study ID #: 99-072
• Secondary ID: CDR0000067675NCI
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: June 18, 2013
• Start date: January 2000
• Est. completion date: May 2001

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2001
• Est. primary completion date: May 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• irofulven

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)