ClinicalTrials.gg
TerminatedNCT00053833Updated Nov 8, 2013

S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 interventional study of irinotecan in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by SWOG Cancer Research Network. Terminated at 100 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Why this study was terminated
lack of accrual
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Sex
Female
01

Study 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 irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Read the detailed description

OBJECTIVES:

  • Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan.
  • Determine the progression-free and overall survival of patients treated with this drug.
  • Evaluate the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

02

Conditions studied

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer

Keywords

  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
03

In context

Fallopian Tube Neoplasms

734 studies on the registry are indexed under Fallopian Tube Neoplasms; 128 are open to participants now.

This study's enrollment of 2 is below the median of 51 across 598 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

    • No mixed mullerian and borderline ovarian tumors
  • Surgically staged as stage III or IV at initial diagnosis
  • Must meet one of the following criteria for refractory/relapsed disease:

    • Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy
    • Had a best response of increasing disease during this front-line regimen

      • Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen
  • Unidimensionally measurable disease

    • At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
    • At least 1 cm by spiral CT scan
    • Measurable disease must remain outside of radiotherapy field
  • If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No angina pectoris
  • No uncontrolled congestive heart failure
  • No uncontrolled cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior biological response modifier
  • At least 28 days since prior biological response modifier and recovered

Chemotherapy

  • See Disease Characteristics
  • No prior topotecan or other topoisomerase I inhibitor
  • One other additional prior chemotherapy regimen allowed
  • At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered

Endocrine therapy

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy

Radiotherapy

  • At least 28 days since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent palliative radiotherapy

Surgery

  • At least 14 days since prior major surgery and recovered

Other

  • At least 28 days since prior investigational drugs and recovered
  • No other concurrent antitumor therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    irinotecan

    irinotecan

    Drug: irinotecan

Interventions

06

Study locations

100 sites
  • MBCCOP - Gulf Coast
    Mobile, Alabama 36688, United States
  • CCOP - Greater Phoenix
    Phoenix, Arizona 85006-2726, United States
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
    Phoenix, Arizona 85012, United States
  • Veterans Affairs Medical Center - Tucson
    Tucson, Arizona 85723, United States
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Veterans Affairs Medical Center - Little Rock (McClellan)
    Little Rock, Arkansas 72205, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • California Cancer Center
    Fresno, California 93720, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • Veterans Affairs Medical Center - West Los Angeles
    Los Angeles, California 90073, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Veterans Affairs Outpatient Clinic - Martinez
    Martinez, California 94553, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California Davis Cancer Center
    Sacramento, California 95817, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California 95403, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • University of Colorado Cancer Center
    Denver, Colorado 80010, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
  • MBCCOP - Howard University Cancer Center
    Washington D.C., District of Columbia 20060, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • Dwight David Eisenhower Army Medical Center
    Fort Gordon, Georgia 30905-5650, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813-2424, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859-5000, United States
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    Chicago, Illinois 60611-W227, United States
  • MBCCOP - University of Illinois at Chicago
    Chicago, Illinois 60612-7323, United States
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois 60612, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    Hines, Illinois 60141, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153-5500, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160-7353, United States
  • CCOP - Wichita
    Wichita, Kansas 67214-3882, United States
  • Veterans Affairs Medical Center - Wichita
    Wichita, Kansas 67218, United States
  • Veterans Affairs Medical Center - Lexington
    Lexington, Kentucky 40502-2236, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Tulane University School of Medicine
    New Orleans, Louisiana 70112, United States
  • Veterans Affairs Medical Center - New Orleans
    New Orleans, Louisiana 70112, United States
  • Louisiana State University Health Sciences Center - Shreveport
    Shreveport, Louisiana 71130-3932, United States
  • Veterans Affairs Medical Center - Shreveport
    Shreveport, Louisiana 71130, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Jamaica Plain, Massachusetts 02130, United States
  • Veterans Affairs Medical Center - Ann Arbor
    Ann Arbor, Michigan 48105, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0912, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • Veterans Affairs Medical Center - Detroit
    Detroit, Michigan 48201-1932, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • CCOP - Grand Rapids
    Grand Rapids, Michigan 49503, United States
  • CCOP - Beaumont
    Royal Oak, Michigan 48073-6769, United States
  • Providence Hospital - Southfield
    Southfield, Michigan 48075-9975, United States
  • Veterans Affairs Medical Center - Biloxi
    Biloxi, Mississippi 39531-2410, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Veterans Affairs Medical Center - Jackson
    Jackson, Mississippi 39216, United States
  • Keesler Medical Center - Keesler AFB
    Keesler Air Force Base, Mississippi 39534-2576, United States
  • Veterans Affairs Medical Center - Kansas City
    Kansas City, Missouri 64128, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65807, United States
  • St. Louis University Health Sciences Center
    St Louis, Missouri 63110, United States
  • CCOP - St. Louis-Cape Girardeau
    St Louis, Missouri 63141, United States
  • CCOP - Montana Cancer Consortium
    Billings, Montana 59101, United States
  • Veterans Affairs Medical Center - Albuquerque
    Albuquerque, New Mexico 87108-5138, United States
  • MBCCOP - University of New Mexico HSC
    Albuquerque, New Mexico 87131, United States
  • Veterans Affairs Medical Center - Albany
    Albany, New York 12208, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • James P. Wilmot Cancer Center at the University of Rochester Medical Center
    Rochester, New York 14642, United States
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina 27104-4241, United States
  • Veterans Affairs Medical Center - Cincinnati
    Cincinnati, Ohio 45220-2288, United States
  • Barrett Cancer Center
    Cincinnati, Ohio 45267-0501, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195-9001, United States
  • CCOP - Columbus
    Columbus, Ohio 43206, United States
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio 43210-1240, United States
  • Veterans Affairs Medical Center - Dayton
    Dayton, Ohio 45428, United States
  • CCOP - Dayton
    Dayton, Ohio 45429, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center - Oklahoma City
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Cancer Institute
    Portland, Oregon 97201-3098, United States
  • Veterans Affairs Medical Center - Portland
    Portland, Oregon 97207, United States
  • CCOP - Columbia River Program
    Portland, Oregon 97225, United States
  • Veterans Affairs Medical Center - Charleston
    Charleston, South Carolina 29401-5799, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425-0721, United States
  • CCOP - Greenville
    Greenville, South Carolina 29615, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • University of Tennessee Cancer Institute
    Memphis, Tennessee 38103, United States
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234-6200, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0565, United States
  • University of Texas - MD Anderson Cancer Center
    Houston, Texas 77030-4095, United States
  • Veterans Affairs Medical Center - Houston
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229-3900, United States
  • Veterans Affairs Medical Center - San Antonio (Murphy)
    San Antonio, Texas 78229, United States
  • Veterans Affairs Medical Center - Temple
    Temple, Texas 76504, United States
  • CCOP - Scott and White Hospital
    Temple, Texas 76508, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112-5550, United States
  • Veterans Affairs Medical Center - Salt Lake City
    Salt Lake City, Utah 84148, United States
  • CCOP - Virginia Mason Research Center
    Seattle, Washington 98101, United States
  • Veterans Affairs Medical Center - Seattle
    Seattle, Washington 98108, United States
  • CCOP - Northwest
    Tacoma, Washington 98405-0986, United States
  • Madigan Army Medical Center
    Tacoma, Washington 98431-5000, United States
  • British Columbia Cancer Agency
    Vancouver, British Columbia V5Z 4E6, Canada
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003, a primary completion of Jul 2004 and a completion of Jul 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2003
First posted
Feb 6, 2003
Start
Apr 2003
Primary completionActual
Jul 2004
CompletionActual
Jul 2004
Last update
Nov 8, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00053833
Responsible party
Sponsor
First posted
Feb 6, 2003
Start date
Apr 2003
Primary completion
Jul 2004
Completion
Jul 2004
Last update
Nov 8, 2013

Study contacts

Amy D. Tiersten, MD
study chair · NYU Langone Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Irinotecan

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