Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00005070
First received: April 6, 2000
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: irofulven
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Advanced Cervical Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: January 2000
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005070

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Carol Aghajanian, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005070     History of Changes
Other Study ID Numbers: 99-072, CDR0000067675, NCI-T99-0096
Study First Received: April 6, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent cervical cancer
stage IVB cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Irofulven
Radiation-Sensitizing Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014