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Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
irofulven
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2000
    Last Updated
    June 18, 2013
    Sponsor
    Memorial Sloan Kettering Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005070
    Brief Title
    Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer
    Official Title
    A Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Advanced Cervical Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    May 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Memorial Sloan Kettering Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    irofulven

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carol Aghajanian, MD
    Organizational Affiliation
    Memorial Sloan Kettering Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

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