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

This study has been terminated.
(lack of accrual)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: February 5, 2003
Last updated: November 7, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: irinotecan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Enrollment: 2
Study Start Date: April 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: irinotecan
Drug: irinotecan
Other Name: camptosar

Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


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


  • 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


Biologic therapy

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


  • 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


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


  • At least 14 days since prior major surgery and recovered


  • At least 28 days since prior investigational drugs and recovered
  • No other concurrent antitumor therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00053833

  Show 100 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Amy D. Tiersten, MD New York University School of Medicine
  More Information

Responsible Party: Southwest Oncology Group Identifier: NCT00053833     History of Changes
Other Study ID Numbers: CDR0000269486
S0025 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: February 5, 2003
Last Updated: November 7, 2013

Keywords provided by Southwest Oncology Group:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017